LABELS · ef45c859-64fd-4af8-a207-d1048bf7049b

ETOPOPHOS

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: 2026-07-31
Captured: 2026-09-09T23:38:02.384588+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE ETOPOPHOS is a topoisomerase inhibitor indicated for the treatment of patients with: Refractory testicular tumors, in combination with other chemotherapeutic drugs. ( 1.1 ) Small cell lung cancer, in combination with cisplatin, as first-line treatment. ( 1.2 ) 1.1 Refractory Testicular Tumors ETOPOPHOS is indicated, in combination with other chemotherapeutic drugs, for treatment of patients with refractory testicular tumors. 1.2 Small Cell Lung Cancer ETOPOPHOS is indicated, in combination with cisplatin, for first-line treatment of patients with small cell lung cancer.

Full extracted label fields

application numbers

NDA020457

boxed warning exact

brand names

ETOPOPHOS

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7499fc35-fae8-44ad-bbab-9a1a589bf3ee

generic names

ETOPOSIDE PHOSPHATE

ef45c859-64fd-4af8-a207-d1048bf7049b

indications and usage exact

1 INDICATIONS AND USAGE ETOPOPHOS is a topoisomerase inhibitor indicated for the treatment of patients with: Refractory testicular tumors, in combination with other chemotherapeutic drugs. ( 1.1 ) Small cell lung cancer, in combination with cisplatin, as first-line treatment. ( 1.2 ) 1.1 Refractory Testicular Tumors ETOPOPHOS is indicated, in combination with other chemotherapeutic drugs, for treatment of patients with refractory testicular tumors. 1.2 Small Cell Lung Cancer ETOPOPHOS is indicated, in combination with cisplatin, for first-line treatment of patients with small cell lung cancer.

indications and usage tables exact

is original packager

true

manufacturer names

H2-Pharma, LLC

matched search terms

cancer
tumors

package ndcs

61269-410-20

product ndcs

61269-410

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Warnings and Precautions, Myelosuppression (5.1) 7/2026

record type

complete_spl_indications_section_candidate

routes

INTRAVENOUS

rxcuis

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00700.json

meta

disclaimer

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.

last updated

2026-09-09

license

https://open.fda.gov/license/

results

limit: 100
skip: 700
total: 830

terms

https://open.fda.gov/terms/

sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%22ef45c859-64fd-4af8-a207-d1048bf7049b%22

spl effective date

2026-07-31

spl effective time

20260731

spl set id

7499fc35-fae8-44ad-bbab-9a1a589bf3ee

spl version

substance names

ETOPOSIDE PHOSPHATE

uniis

528XYJ8L1N

verification flags

oncology_keyword_candidate_not_clinically_classified
spl_text_not_verified_identical_to_latest_approved_label
individual_indications_not_split_or_reconciled
fda_label_posted_after_spl_effective_date_requires_version_review

Drugs@FDA application source records

application number
NDA020457
payload
all indexed label documents
Appl No
020457
Application Docs Date
2011-03-21 00:00:00
Application Docs ID
12607
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020457s013lbl.pdf
Submission No
13
Submission Type
SUPPL
Appl No
020457
Application Docs Date
2015-08-04 00:00:00
Application Docs ID
34676
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020457s014lbl.pdf
Submission No
14
Submission Type
SUPPL
Appl No
020457
Application Docs Date
2016-11-16 00:00:00
Application Docs ID
45898
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020457s015lbl.pdf
Submission No
15
Submission Type
SUPPL
Appl No
020457
Application Docs Date
2017-05-25 00:00:00
Application Docs ID
48539
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020457s016lbl.pdf
Submission No
16
Submission Type
SUPPL
Appl No
020457
Application Docs Date
2019-05-03 00:00:00
Application Docs ID
58545
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020457s019lbl.pdf
Submission No
19
Submission Type
SUPPL
Appl No
020457
Application Docs Date
2026-09-08 00:00:00
Application Docs ID
87162
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020457s020lbl.pdf
Submission No
20
Submission Type
SUPPL
all submission records
Appl No
020457
Review Priority
STANDARD
Submission Class Code ID
9
Submission No
1
Submission Status
AP
Submission Status Date
1996-05-17 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
020457
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
2
Submission Status
AP
Submission Status Date
2001-12-21 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020457
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
3
Submission Status
AP
Submission Status Date
2002-02-21 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020457
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
4
Submission Status
AP
Submission Status Date
2002-02-21 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020457
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
5
Submission Status
AP
Submission Status Date
1999-08-16 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020457
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
6
Submission Status
AP
Submission Status Date
2002-11-05 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020457
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
13
Submission Status
AP
Submission Status Date
2011-03-17 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020457
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
14
Submission Status
AP
Submission Status Date
2015-07-30 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020457
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
15
Submission Status
AP
Submission Status Date
2016-11-09 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020457
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
16
Submission Status
AP
Submission Status Date
2017-05-23 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020457
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
19
Submission Status
AP
Submission Status Date
2019-05-02 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020457
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
20
Submission Status
AP
Submission Status Date
2026-09-02 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA020457
approval interpretation
Application linkage and approved submission are not indication-level current approval verification
current indication status
not_reconciled
drugsfda url
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020457
has approved submission record
true
latest approved submission date
2026-09-02
latest label selection rule
max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
latest posted label documents
Appl No
020457
Application Docs Date
2026-09-08 00:00:00
Application Docs ID
87162
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020457s020lbl.pdf
Submission No
20
Submission Type
SUPPL
official application record
Appl No
020457
Appl Public Notes
Appl Type
NDA
Sponsor Name
CHEPLAPHARM
openfda application present
true
products
Active Ingredient
ETOPOSIDE PHOSPHATE
Appl No
020457
Drug Name
ETOPOPHOS PRESERVATIVE FREE
Form
INJECTABLE;INJECTION
Product No
001
Reference Drug
1
Reference Standard
1
Strength
EQ 100MG BASE/VIAL
marketing status
Prescription

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

NDA020457

brand names

ETOPOPHOS

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

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content role

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context span

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exact text: 1 INDICATIONS AND USAGE ETOPOPHOS is a topoisomerase inhibitor indicated for the treatment of patients with: Refractory testicular tumors, in combination with other chemotherapeutic drugs. ( 1.1 ) Small cell lung cancer, in combination with cisplatin, as first-line treatment. ( 1.2 ) 1.1 Refractory Testicular Tumors ETOPOPHOS is indicated, in combination with other chemotherapeutic dru
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current approval status

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extraction review status

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generic names

ETOPOSIDE PHOSPHATE

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label id

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qualifier mentions

context exact
ase inhibitor indicated for the treatment of patients with: Refractory testicular tumors, in combination with other chemotherapeutic drugs.
kind
stage_or_setting
polarity
not_inferred
span
end
137
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exact text
Refractory testicular tumors
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context exact
e treatment of patients with: Refractory testicular tumors, in combination with other chemotherapeutic drugs.
kind
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exact text
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regulatory links

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exact text: 1 INDICATIONS AND USAGE ETOPOPHOS is a topoisomerase inhibitor indicated for the treatment of patients with: Refractory testicular tumors, in combination with other chemotherapeutic drugs.
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source text sha256: 826ba60f69d953406217bc95f16d449fdb72e6ce685a0b87c46b4867e3188f89
start: 0

source url

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spl effective date

2026-07-31

spl set id

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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 · positive indication candidate

application numbers

NDA020457

brand names

ETOPOPHOS

classification reasons

inherited_predicate_from_same_label_section_requires_review
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

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context span

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exact text: 1 INDICATIONS AND USAGE ETOPOPHOS is a topoisomerase inhibitor indicated for the treatment of patients with: Refractory testicular tumors, in combination with other chemotherapeutic drugs. ( 1.1 ) Small cell lung cancer, in combination with cisplatin, as first-line treatment. ( 1.2 ) 1.1 Refractory Testicular Tumors ETOPOPHOS is indicated, in combination with other chemotherapeutic drugs, for treatment of patients with refractory testicular tumors. 1.2 Small Cell Lung Can
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extraction review status

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generic names

ETOPOSIDE PHOSPHATE

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label id

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qualifier mentions

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source url

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spl effective date

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spl set id

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structured indication

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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 3 · unclassified context

application numbers

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brand names

ETOPOPHOS

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clinical review status

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exact text: the treatment of patients with: Refractory testicular tumors, in combination with other chemotherapeutic drugs. ( 1.1 ) Small cell lung cancer, in combination with cisplatin, as first-line treatment. ( 1.2 ) 1.1 Refractory Testicular Tumors ETOPOPHOS is indicated, in combination with other chemotherapeutic drugs, for treatment of patients with refractory testicular tumors. 1.2 Small Cell Lung Cancer ETOP
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source url

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limitations: Source null
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tumor histology: Source null

use intent

unclear

Passage 4 · positive indication candidate

application numbers

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brand names

ETOPOPHOS

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exact text: tment of patients with: Refractory testicular tumors, in combination with other chemotherapeutic drugs. ( 1.1 ) Small cell lung cancer, in combination with cisplatin, as first-line treatment. ( 1.2 ) 1.1 Refractory Testicular Tumors ETOPOPHOS is indicated, in combination with other chemotherapeutic drugs, for treatment of patients with refractory testicular tumors. 1.2 Small Cell Lung Cancer ETOPOPHOS is indicated, in combination with cisplatin, for first-line treatment of patients with small cell lung cancer.
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1.1 Refractory Testicular Tumors ETOPOPHOS is indicated, in combination with other chemotherapeutic drugs, fo
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Refractory Testicular Tumors ETOPOPHOS is ind
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exact text: 1.1 Refractory Testicular Tumors ETOPOPHOS is indicated, in combination with other chemotherapeutic drugs, for treatment of patients with refractory testicular tumors.
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source url

https://api.fda.gov/drug/label.json?search=id%3A%22ef45c859-64fd-4af8-a207-d1048bf7049b%22

spl effective date

2026-07-31

spl set id

7499fc35-fae8-44ad-bbab-9a1a589bf3ee

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 5 · positive indication candidate

application numbers

NDA020457

brand names

ETOPOPHOS

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: 600
end exclusive: true
exact text: s first-line treatment. ( 1.2 ) 1.1 Refractory Testicular Tumors ETOPOPHOS is indicated, in combination with other chemotherapeutic drugs, for treatment of patients with refractory testicular tumors. 1.2 Small Cell Lung Cancer ETOPOPHOS is indicated, in combination with cisplatin, for first-line treatment of patients with small cell lung cancer.
label id: ef45c859-64fd-4af8-a207-d1048bf7049b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 826ba60f69d953406217bc95f16d449fdb72e6ce685a0b87c46b4867e3188f89
start: 253

current approval status

not_reconciled

duplicate text group

dup-b6cb146fac23e9ab118a

extraction review status

automated_candidate_pending_source_review

generic names

ETOPOSIDE PHOSPHATE

ind-span-07c52cc78cb799f630bc

label id

ef45c859-64fd-4af8-a207-d1048bf7049b

positive predicate support span

end: 502
end exclusive: true
exact text: is indicated
label id: ef45c859-64fd-4af8-a207-d1048bf7049b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 826ba60f69d953406217bc95f16d449fdb72e6ce685a0b87c46b4867e3188f89
start: 490

qualifier mentions

context exact
ETOPOPHOS is indicated, in combination with cisplatin, for first-line treatment of patients with small cell lung cancer.
kind
prior_therapy_or_line
polarity
not_inferred
span
end
599
end exclusive
true
exact text
first-line treatment of patients with small cell lung cancer
label id
ef45c859-64fd-4af8-a207-d1048bf7049b
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source array index
0
source field
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source text sha256
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start
539
context exact
1.2 Small Cell Lung Cancer ETOPOPHOS is indicated, in combination with cisplatin, for first-line treatment of patients with small cell lung cancer.
kind
regimen
polarity
not_inferred
span
end
599
end exclusive
true
exact text
in combination with cisplatin, for first-line treatment of patients with small cell lung cancer
label id
ef45c859-64fd-4af8-a207-d1048bf7049b
offset unit
unicode_code_points
source array index
0
source field
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source text sha256
826ba60f69d953406217bc95f16d449fdb72e6ce685a0b87c46b4867e3188f89
start
504

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

source span

end: 600
end exclusive: true
exact text: 1.2 Small Cell Lung Cancer ETOPOPHOS is indicated, in combination with cisplatin, for first-line treatment of patients with small cell lung cancer.
label id: ef45c859-64fd-4af8-a207-d1048bf7049b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 826ba60f69d953406217bc95f16d449fdb72e6ce685a0b87c46b4867e3188f89
start: 453

source url

https://api.fda.gov/drug/label.json?search=id%3A%22ef45c859-64fd-4af8-a207-d1048bf7049b%22

spl effective date

2026-07-31

spl set id

7499fc35-fae8-44ad-bbab-9a1a589bf3ee

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

Preserved source evidence · Not medical advice