LABELS · 049982fe-a321-b868-e063-6294a90ae861

GEMCITABINE

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date: 2023-09-11
Captured: 2026-09-09T23:37:39.774134+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE Gemcitabine Injection is a nucleoside metabolic inhibitor indicated: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. ( 1.1 ) in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. ( 1.2 ) in combination with cisplatin for the treatment of non-small cell lung cancer. ( 1.3 ) as a single agent for the treatment of pancreatic cancer. ( 1.4 ) 1.1 Ovarian Cancer Gemcitabine Injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. 1.2 Breast Cancer Gemcitabine Injection in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. 1.3 Non-Small Cell Lung Cancer Gemcitabine Injection is indicated in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer (NSCLC). 1.4 Pancreatic Cancer Gemcitabine Injection is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemcitabine Injection is indicated for patients previously treated with fluorouracil.

Full extracted label fields

application numbers

NDA209604

boxed warning exact

brand names

GEMCITABINE

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4031017d-d768-46de-8081-476bcb883f5e

generic names

GEMCITABINE

049982fe-a321-b868-e063-6294a90ae861

indications and usage exact

1 INDICATIONS AND USAGE Gemcitabine Injection is a nucleoside metabolic inhibitor indicated: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. ( 1.1 ) in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. ( 1.2 ) in combination with cisplatin for the treatment of non-small cell lung cancer. ( 1.3 ) as a single agent for the treatment of pancreatic cancer. ( 1.4 ) 1.1 Ovarian Cancer Gemcitabine Injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. 1.2 Breast Cancer Gemcitabine Injection in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. 1.3 Non-Small Cell Lung Cancer Gemcitabine Injection is indicated in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer (NSCLC). 1.4 Pancreatic Cancer Gemcitabine Injection is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemcitabine Injection is indicated for patients previously treated with fluorouracil.

indications and usage tables exact

is original packager

true

manufacturer names

BluePoint Laboratories

matched search terms

cancer

package ndcs

68001-342-34
68001-348-36
68001-350-68
68001-359-37

product ndcs

68001-342
68001-348
68001-350
68001-359

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Warnings and Precautions, Hemolytic Uremic Syndrome (5.4)

record type

complete_spl_indications_section_candidate

routes

INTRAVENOUS

rxcuis

1998783

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00000.json

Source passages and status connections

Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

Passage 1 · positive indication candidate

application numbers

NDA209604

brand names

GEMCITABINE

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 450
end exclusive: true
exact text: 1 INDICATIONS AND USAGE Gemcitabine Injection is a nucleoside metabolic inhibitor indicated: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. ( 1.1 ) in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinical
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 0

current approval status

not_reconciled

duplicate text group

dup-937da292467f69bfc96f

extraction review status

automated_candidate_pending_source_review

generic names

GEMCITABINE

ind-span-14ad08c9a79cc9e62fa1

label id

049982fe-a321-b868-e063-6294a90ae861

positive predicate support span

end: 91
end exclusive: true
exact text: is a nucleoside metabolic inhibitor indicated
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 46

qualifier mentions

context exact
INDICATIONS AND USAGE Gemcitabine Injection is a nucleoside metabolic inhibitor indicated: in combination with carboplatin, for the treatment of advanced ovarian c
kind
biomarker
polarity
not_inferred
span
end
105
end exclusive
true
exact text
metabolic inhibitor indicated: in combinati
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
62
context exact
ated: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.
kind
stage_or_setting
polarity
not_inferred
span
end
190
end exclusive
true
exact text
advanced ovarian cancer that has relapsed a
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
147
context exact
ne Injection is a nucleoside metabolic inhibitor indicated: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.
kind
regimen
polarity
not_inferred
span
end
249
end exclusive
true
exact text
in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
93

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
1389
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
1355

source span

end: 250
end exclusive: true
exact text: 1 INDICATIONS AND USAGE Gemcitabine Injection is a nucleoside metabolic inhibitor indicated: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%22049982fe-a321-b868-e063-6294a90ae861%22

spl effective date

2023-09-11

spl set id

4031017d-d768-46de-8081-476bcb883f5e

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

tumor_directed_candidate

Passage 2 · unclassified context

application numbers

NDA209604

brand names

GEMCITABINE

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 458
end exclusive: true
exact text: nucleoside metabolic inhibitor indicated: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. ( 1.1 ) in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contr
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 51

current approval status

not_reconciled

duplicate text group

dup-b3b5eb2b27188d32621f

extraction review status

automated_candidate_pending_source_review

generic names

GEMCITABINE

ind-span-45d6c77c220ed63c7ea7

label id

049982fe-a321-b868-e063-6294a90ae861

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
1389
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
1355

source span

end: 258
end exclusive: true
exact text: ( 1.1 )
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 251

source url

https://api.fda.gov/drug/label.json?search=id%3A%22049982fe-a321-b868-e063-6294a90ae861%22

spl effective date

2023-09-11

spl set id

4031017d-d768-46de-8081-476bcb883f5e

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 3 · risk or warning

application numbers

NDA209604

brand names

GEMCITABINE

classification reasons

risk_or_warning_words_without_positive_predicate

clinical review status

pending

content role

risk_or_warning

context span

end: 669
end exclusive: true
exact text: de metabolic inhibitor indicated: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. ( 1.1 ) in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. ( 1.2 ) in combination with cisplatin for the treatment of non-small cell lung cancer. ( 1.3 ) as a single agent for the treatment of pancreatic cancer. ( 1.4 ) 1.1 Ovarian Cancer Gemcitabine Injecti
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 59

current approval status

not_reconciled

duplicate text group

dup-4b567d12095bb4584ffd

extraction review status

automated_candidate_pending_source_review

generic names

GEMCITABINE

ind-span-615e324c2f16585b4d6d

label id

049982fe-a321-b868-e063-6294a90ae861

positive predicate support span

Source null

qualifier mentions

context exact
in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless
kind
biomarker
polarity
not_inferred
span
end
362
end exclusive
true
exact text
metastatic breast cancer after failure of p
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
319
context exact
in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless an
kind
stage_or_setting
polarity
not_inferred
span
end
364
end exclusive
true
exact text
metastatic breast cancer after failure of pri
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
319
context exact
east cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.
kind
stage_or_setting
polarity
not_inferred
span
end
413
end exclusive
true
exact text
adjuvant chemotherapy
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
392
context exact
in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.
kind
prior_therapy_or_line
polarity
not_inferred
span
end
465
end exclusive
true
exact text
first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindica
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
295
context exact
in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.
kind
regimen
polarity
not_inferred
span
end
438
end exclusive
true
exact text
in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines w
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
259

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
1389
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
1355

source span

end: 469
end exclusive: true
exact text: in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 259

source url

https://api.fda.gov/drug/label.json?search=id%3A%22049982fe-a321-b868-e063-6294a90ae861%22

spl effective date

2023-09-11

spl set id

4031017d-d768-46de-8081-476bcb883f5e

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Passage 4 · unclassified context

application numbers

NDA209604

brand names

GEMCITABINE

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 677
end exclusive: true
exact text: ion with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. ( 1.2 ) in combination with cisplatin for the treatment of non-small cell lung cancer. ( 1.3 ) as a single agent for the treatment of pancreatic cancer. ( 1.4 ) 1.1 Ovarian Cancer Gemcitabine Injection in co
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 270

current approval status

not_reconciled

duplicate text group

dup-e4f2e8431a9ce99e8970

extraction review status

automated_candidate_pending_source_review

generic names

GEMCITABINE

ind-span-26de4d92606bb2173366

label id

049982fe-a321-b868-e063-6294a90ae861

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
1389
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
1355

source span

end: 477
end exclusive: true
exact text: ( 1.2 )
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 470

source url

https://api.fda.gov/drug/label.json?search=id%3A%22049982fe-a321-b868-e063-6294a90ae861%22

spl effective date

2023-09-11

spl set id

4031017d-d768-46de-8081-476bcb883f5e

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 5 · unclassified context

application numbers

NDA209604

brand names

GEMCITABINE

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 756
end exclusive: true
exact text: paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. ( 1.2 ) in combination with cisplatin for the treatment of non-small cell lung cancer. ( 1.3 ) as a single agent for the treatment of pancreatic cancer. ( 1.4 ) 1.1 Ovarian Cancer Gemcitabine Injection in combination with carboplatin is indicated for the treatment of patients with adva
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 278

current approval status

not_reconciled

duplicate text group

dup-c1b9f48f41cd23397206

extraction review status

automated_candidate_pending_source_review

generic names

GEMCITABINE

ind-span-160971ef30a4ee435b27

label id

049982fe-a321-b868-e063-6294a90ae861

positive predicate support span

Source null

qualifier mentions

context exact
in combination with cisplatin for the treatment of non-small cell lung cancer.
kind
regimen
polarity
not_inferred
span
end
555
end exclusive
true
exact text
in combination with cisplatin for the treatment of non-small cell lung cancer
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
478

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
1389
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
1355

source span

end: 556
end exclusive: true
exact text: in combination with cisplatin for the treatment of non-small cell lung cancer.
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 478

source url

https://api.fda.gov/drug/label.json?search=id%3A%22049982fe-a321-b868-e063-6294a90ae861%22

spl effective date

2023-09-11

spl set id

4031017d-d768-46de-8081-476bcb883f5e

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 6 · unclassified context

application numbers

NDA209604

brand names

GEMCITABINE

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 764
end exclusive: true
exact text: of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. ( 1.2 ) in combination with cisplatin for the treatment of non-small cell lung cancer. ( 1.3 ) as a single agent for the treatment of pancreatic cancer. ( 1.4 ) 1.1 Ovarian Cancer Gemcitabine Injection in combination with carboplatin is indicated for the treatment of patients with advanced ova
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 357

current approval status

not_reconciled

duplicate text group

dup-a26de7bdcc9c206ded9d

extraction review status

automated_candidate_pending_source_review

generic names

GEMCITABINE

ind-span-bcb71fb5ed86ea3ac28e

label id

049982fe-a321-b868-e063-6294a90ae861

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
1389
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
1355

source span

end: 564
end exclusive: true
exact text: ( 1.3 )
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 557

source url

https://api.fda.gov/drug/label.json?search=id%3A%22049982fe-a321-b868-e063-6294a90ae861%22

spl effective date

2023-09-11

spl set id

4031017d-d768-46de-8081-476bcb883f5e

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 7 · unclassified context

application numbers

NDA209604

brand names

GEMCITABINE

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 822
end exclusive: true
exact text: r anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. ( 1.2 ) in combination with cisplatin for the treatment of non-small cell lung cancer. ( 1.3 ) as a single agent for the treatment of pancreatic cancer. ( 1.4 ) 1.1 Ovarian Cancer Gemcitabine Injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after comp
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 365

current approval status

not_reconciled

duplicate text group

dup-9f836192ecfb1e5352e3

extraction review status

automated_candidate_pending_source_review

generic names

GEMCITABINE

ind-span-eafddb5bd0bab60536f6

label id

049982fe-a321-b868-e063-6294a90ae861

positive predicate support span

Source null

qualifier mentions

context exact
as a single agent for the treatment of pancreatic cancer.
kind
regimen
polarity
not_inferred
span
end
621
end exclusive
true
exact text
as a single agent for the treatment of pancreatic cancer
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
565

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
1389
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
1355

source span

end: 622
end exclusive: true
exact text: as a single agent for the treatment of pancreatic cancer.
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 565

source url

https://api.fda.gov/drug/label.json?search=id%3A%22049982fe-a321-b868-e063-6294a90ae861%22

spl effective date

2023-09-11

spl set id

4031017d-d768-46de-8081-476bcb883f5e

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 8 · unclassified context

application numbers

NDA209604

brand names

GEMCITABINE

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 830
end exclusive: true
exact text: nthracyclines were clinically contraindicated. ( 1.2 ) in combination with cisplatin for the treatment of non-small cell lung cancer. ( 1.3 ) as a single agent for the treatment of pancreatic cancer. ( 1.4 ) 1.1 Ovarian Cancer Gemcitabine Injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion o
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 423

current approval status

not_reconciled

duplicate text group

dup-356d85d2c6b238fdee3e

extraction review status

automated_candidate_pending_source_review

generic names

GEMCITABINE

ind-span-a346b4b10a4b97a40fae

label id

049982fe-a321-b868-e063-6294a90ae861

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
1389
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
1355

source span

end: 630
end exclusive: true
exact text: ( 1.4 )
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 623

source url

https://api.fda.gov/drug/label.json?search=id%3A%22049982fe-a321-b868-e063-6294a90ae861%22

spl effective date

2023-09-11

spl set id

4031017d-d768-46de-8081-476bcb883f5e

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 9 · positive indication candidate

application numbers

NDA209604

brand names

GEMCITABINE

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 1055
end exclusive: true
exact text: lines were clinically contraindicated. ( 1.2 ) in combination with cisplatin for the treatment of non-small cell lung cancer. ( 1.3 ) as a single agent for the treatment of pancreatic cancer. ( 1.4 ) 1.1 Ovarian Cancer Gemcitabine Injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. 1.2 Breast Cancer Gemcitabine Injection in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-contain
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 431

current approval status

not_reconciled

duplicate text group

dup-bd54a1efc92af4582a0a

extraction review status

automated_candidate_pending_source_review

generic names

GEMCITABINE

ind-span-3077fd9d5fa012420a48

label id

049982fe-a321-b868-e063-6294a90ae861

positive predicate support span

end: 716
end exclusive: true
exact text: is indicated
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 704

qualifier mentions

context exact
carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.
kind
stage_or_setting
polarity
not_inferred
span
end
795
end exclusive
true
exact text
advanced ovarian cancer that has relapsed a
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
752
context exact
1.1 Ovarian Cancer Gemcitabine Injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.
kind
regimen
polarity
not_inferred
span
end
851
end exclusive
true
exact text
in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based ther
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
672

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
1389
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
1355

source span

end: 855
end exclusive: true
exact text: 1.1 Ovarian Cancer Gemcitabine Injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 631

source url

https://api.fda.gov/drug/label.json?search=id%3A%22049982fe-a321-b868-e063-6294a90ae861%22

spl effective date

2023-09-11

spl set id

4031017d-d768-46de-8081-476bcb883f5e

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

tumor_directed_candidate

Passage 10 · positive indication candidate

application numbers

NDA209604

brand names

GEMCITABINE

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement
positive_statement_also_contains_qualification_review_required

clinical review status

pending

content role

positive_indication_candidate

context span

end: 1336
end exclusive: true
exact text: abine Injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. 1.2 Breast Cancer Gemcitabine Injection in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. 1.3 Non-Small Cell Lung Cancer Gemcitabine Injection is indicated in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB), or met
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 656

current approval status

not_reconciled

duplicate text group

dup-86170673a096eb55d220

extraction review status

automated_candidate_pending_source_review

generic names

GEMCITABINE

ind-span-80894bd455a44698e580

label id

049982fe-a321-b868-e063-6294a90ae861

positive predicate support span

end: 939
end exclusive: true
exact text: is indicated
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 927

qualifier mentions

context exact
is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless
kind
biomarker
polarity
not_inferred
span
end
1029
end exclusive
true
exact text
metastatic breast cancer after failure of p
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
986
context exact
is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless an
kind
stage_or_setting
polarity
not_inferred
span
end
1031
end exclusive
true
exact text
metastatic breast cancer after failure of pri
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
986
context exact
east cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.
kind
stage_or_setting
polarity
not_inferred
span
end
1080
end exclusive
true
exact text
adjuvant chemotherapy
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
1059
context exact
jection in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.
kind
prior_therapy_or_line
polarity
not_inferred
span
end
1118
end exclusive
true
exact text
first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinicall
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
948
context exact
1.2 Breast Cancer Gemcitabine Injection in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated
kind
regimen
polarity
not_inferred
span
end
1075
end exclusive
true
exact text
in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemoth
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
896

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
1389
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
1355

source span

end: 1136
end exclusive: true
exact text: 1.2 Breast Cancer Gemcitabine Injection in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 856

source url

https://api.fda.gov/drug/label.json?search=id%3A%22049982fe-a321-b868-e063-6294a90ae861%22

spl effective date

2023-09-11

spl set id

4031017d-d768-46de-8081-476bcb883f5e

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

tumor_directed_candidate

Passage 11 · positive indication candidate

application numbers

NDA209604

brand names

GEMCITABINE

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 1590
end exclusive: true
exact text: ed for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. 1.3 Non-Small Cell Lung Cancer Gemcitabine Injection is indicated in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer (NSCLC). 1.4 Pancreatic Cancer Gemcitabine Injection is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of th
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 937

current approval status

not_reconciled

duplicate text group

dup-8aa3200b6df689335b42

extraction review status

automated_candidate_pending_source_review

generic names

GEMCITABINE

ind-span-eed3e69d3ec313e96740

label id

049982fe-a321-b868-e063-6294a90ae861

positive predicate support span

end: 1202
end exclusive: true
exact text: is indicated
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 1190

qualifier mentions

context exact
with inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer (NSCLC).
kind
biomarker
polarity
not_inferred
span
end
1376
end exclusive
true
exact text
metastatic (Stage IV) non-small cell lung c
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
1333
context exact
n for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer (NSCLC
kind
stage_or_setting
polarity
not_inferred
span
end
1328
end exclusive
true
exact text
locally advanced (Stage IIIA or IIIB)
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
1291
context exact
with inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer (NSCLC).
kind
stage_or_setting
polarity
not_inferred
span
end
1378
end exclusive
true
exact text
metastatic (Stage IV) non-small cell lung can
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
1333
context exact
njection is indicated in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer (NSCLC).
kind
prior_therapy_or_line
polarity
not_inferred
span
end
1389
end exclusive
true
exact text
first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer (NSCLC)
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
1241
context exact
n-Small Cell Lung Cancer Gemcitabine Injection is indicated in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer (NSCLC).
kind
regimen
polarity
not_inferred
span
end
1382
end exclusive
true
exact text
in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
1203

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
1389
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
1355

source span

end: 1390
end exclusive: true
exact text: 1.3 Non-Small Cell Lung Cancer Gemcitabine Injection is indicated in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer (NSCLC).
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 1137

source url

https://api.fda.gov/drug/label.json?search=id%3A%22049982fe-a321-b868-e063-6294a90ae861%22

spl effective date

2023-09-11

spl set id

4031017d-d768-46de-8081-476bcb883f5e

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

tumor_directed_candidate

Passage 12 · positive indication candidate

application numbers

NDA209604

brand names

GEMCITABINE

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 1687
end exclusive: true
exact text: s indicated in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer (NSCLC). 1.4 Pancreatic Cancer Gemcitabine Injection is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemcitabine Injection is indicated for patients previously treated with fluorouracil.
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 1191

current approval status

not_reconciled

duplicate text group

dup-28cb6a084c987b1c3379

extraction review status

automated_candidate_pending_source_review

generic names

GEMCITABINE

ind-span-fe5a80546a25a777cc13

label id

049982fe-a321-b868-e063-6294a90ae861

positive predicate support span

end: 1447
end exclusive: true
exact text: is indicated
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 1435

qualifier mentions

context exact
h locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas.
kind
biomarker
polarity
not_inferred
span
end
1591
end exclusive
true
exact text
metastatic (Stage IV) adenocarcinoma of the
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
1548
context exact
tion is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas.
kind
stage_or_setting
polarity
not_inferred
span
end
1541
end exclusive
true
exact text
locally advanced (nonresectable Stage II or Stage I
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
1490
context exact
h locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas.
kind
stage_or_setting
polarity
not_inferred
span
end
1593
end exclusive
true
exact text
metastatic (Stage IV) adenocarcinoma of the p
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
1548
context exact
1.4 Pancreatic Cancer Gemcitabine Injection is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas.
kind
prior_therapy_or_line
polarity
not_inferred
span
end
1600
end exclusive
true
exact text
first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
1451

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
1389
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
1355

source span

end: 1601
end exclusive: true
exact text: 1.4 Pancreatic Cancer Gemcitabine Injection is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas.
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 1391

source url

https://api.fda.gov/drug/label.json?search=id%3A%22049982fe-a321-b868-e063-6294a90ae861%22

spl effective date

2023-09-11

spl set id

4031017d-d768-46de-8081-476bcb883f5e

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

tumor_directed_candidate

Passage 13 · positive indication candidate

application numbers

NDA209604

brand names

GEMCITABINE

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 1687
end exclusive: true
exact text: tic Cancer Gemcitabine Injection is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemcitabine Injection is indicated for patients previously treated with fluorouracil.
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 1402

current approval status

not_reconciled

duplicate text group

dup-c99944d069bc770498fa

extraction review status

automated_candidate_pending_source_review

generic names

GEMCITABINE

ind-span-1b191f57176543514af5

label id

049982fe-a321-b868-e063-6294a90ae861

positive predicate support span

end: 1636
end exclusive: true
exact text: is indicated
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 1624

qualifier mentions

context exact
Gemcitabine Injection is indicated for patients previously treated with fluorouracil.
kind
prior_therapy_or_line
polarity
not_inferred
span
end
1686
end exclusive
true
exact text
previously treated with fluorouracil
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
1650

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
1389
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
049982fe-a321-b868-e063-6294a90ae861
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start
1355

source span

end: 1687
end exclusive: true
exact text: Gemcitabine Injection is indicated for patients previously treated with fluorouracil.
label id: 049982fe-a321-b868-e063-6294a90ae861
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: f43d5bbb40fd065ca9e823b0a6cc144f74fe3bf61d926871d4eee2d20e1ed489
start: 1602

source url

https://api.fda.gov/drug/label.json?search=id%3A%22049982fe-a321-b868-e063-6294a90ae861%22

spl effective date

2023-09-11

spl set id

4031017d-d768-46de-8081-476bcb883f5e

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Preserved source evidence · Not medical advice