LABELS · 40ceddc0-83a2-4b3b-8953-fd0078a41133

TEMODAR

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: 2026-02-20
Captured: 2026-09-09T23:37:44.904352+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE TEMODAR is an alkylating drug indicated for the treatment of adults with: Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. ( 1.1 ) Anaplastic astrocytoma. ( 1.2 ) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. ( 1.2 ) Treatment of adults with refractory anaplastic astrocytoma. ( 1.2 ) 1.1 Newly Diagnosed Glioblastoma TEMODAR is indicated for the treatment of adults with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance treatment. 1.2 Anaplastic Astrocytoma TEMODAR is indicated for the: adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma; treatment of adults with refractory anaplastic astrocytoma.

Full extracted label fields

application numbers

NDA021029
NDA022277

boxed warning exact

brand names

TEMODAR

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=046a9011-3911-4d3f-a15f-fbb56d5aad56

generic names

TEMOZOLOMIDE

40ceddc0-83a2-4b3b-8953-fd0078a41133

indications and usage exact

1 INDICATIONS AND USAGE TEMODAR is an alkylating drug indicated for the treatment of adults with: Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. ( 1.1 ) Anaplastic astrocytoma. ( 1.2 ) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. ( 1.2 ) Treatment of adults with refractory anaplastic astrocytoma. ( 1.2 ) 1.1 Newly Diagnosed Glioblastoma TEMODAR is indicated for the treatment of adults with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance treatment. 1.2 Anaplastic Astrocytoma TEMODAR is indicated for the: adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma; treatment of adults with refractory anaplastic astrocytoma.

indications and usage tables exact

is original packager

true

manufacturer names

Merck Sharp & Dohme LLC

matched search terms

glioblastoma

package ndcs

0085-3004-05
0085-3004-03
0085-3004-04
0085-1519-05
0085-1519-03
0085-1519-04
0085-1366-05
0085-1366-03
0085-1366-04
0085-1425-05
0085-1425-03
0085-1425-04

product ndcs

0085-1366
0085-3004
0085-1519
0085-1425
0085-1430
0085-1417
0085-1381

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

ORAL
INTRAVENOUS

rxcuis

261288
261289
261290
261291
313209
313210
313211
317160
700883
700885
705617
705619

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00200.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: 200
total: 830

terms

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

sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%2240ceddc0-83a2-4b3b-8953-fd0078a41133%22

spl effective date

2026-02-20

spl effective time

20260220

spl set id

046a9011-3911-4d3f-a15f-fbb56d5aad56

spl version

substance names

TEMOZOLOMIDE

uniis

YF1K15M17Y

verification flags

oncology_keyword_candidate_not_clinically_classified
spl_text_not_verified_identical_to_latest_approved_label
individual_indications_not_split_or_reconciled

Drugs@FDA application source records

application number
NDA021029
payload
all indexed label documents
Appl No
021029
Application Docs Date
2002-01-18 00:00:00
Application Docs ID
14198
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/021029-S004_TEMODAR_lbl.pdf
Submission No
4
Submission Type
SUPPL
Appl No
021029
Application Docs Date
2005-03-15 00:00:00
Application Docs ID
14199
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021029s008lbl.pdf
Submission No
8
Submission Type
SUPPL
Appl No
021029
Application Docs Date
2011-02-09 00:00:00
Application Docs ID
14200
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021029s020,022277s004lbl.pdf
Submission No
20
Submission Type
SUPPL
Appl No
021029
Application Docs Date
2011-06-07 00:00:00
Application Docs ID
14201
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021029s021,022277s005lbl.pdf
Submission No
21
Submission Type
SUPPL
Appl No
021029
Application Docs Date
2015-09-23 00:00:00
Application Docs ID
14202
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
Submission No
29
Submission Type
SUPPL
Appl No
021029
Application Docs Date
2016-02-18 00:00:00
Application Docs ID
14203
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021029s031lbl.pdf
Submission No
31
Submission Type
SUPPL
Appl No
021029
Application Docs Date
1999-08-11 00:00:00
Application Docs ID
35930
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21029lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
021029
Application Docs Date
2003-03-26 00:00:00
Application Docs ID
35931
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21029se8-005_temodar_lbl.pdf
Submission No
5
Submission Type
SUPPL
Appl No
021029
Application Docs Date
2006-10-23 00:00:00
Application Docs ID
35932
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021029s012lbl.pdf
Submission No
12
Submission Type
SUPPL
Appl No
021029
Application Docs Date
2010-04-28 00:00:00
Application Docs ID
35933
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021029s018lbl.pdf
Submission No
18
Submission Type
SUPPL
Appl No
021029
Application Docs Date
2013-01-09 00:00:00
Application Docs ID
35934
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021029s022lbl.pdf
Submission No
22
Submission Type
SUPPL
Appl No
021029
Application Docs Date
2014-05-06 00:00:00
Application Docs ID
35935
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021029s026lbl.pdf
Submission No
26
Submission Type
SUPPL
all submission records
Appl No
021029
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
38
Submission Status
AP
Submission Status Date
2023-09-14 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021029
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
37
Submission Status
AP
Submission Status Date
2023-09-14 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021029
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
36
Submission Status
AP
Submission Status Date
2023-09-14 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021029
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
35
Submission Status
AP
Submission Status Date
2020-11-20 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021029
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
33
Submission Status
AP
Submission Status Date
2019-11-22 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021029
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
32
Submission Status
AP
Submission Status Date
2017-10-06 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021029
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
31
Submission Status
AP
Submission Status Date
2016-02-12 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021029
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
30
Submission Status
AP
Submission Status Date
2017-02-24 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021029
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
29
Submission Status
AP
Submission Status Date
2015-09-18 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021029
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
28
Submission Status
AP
Submission Status Date
2015-04-02 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021029
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
27
Submission Status
AP
Submission Status Date
2014-09-19 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
021029
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
26
Submission Status
AP
Submission Status Date
2014-05-05 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA021029
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=021029
has approved submission record
true
latest approved submission date
2023-09-14
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
021029
Application Docs Date
2023-09-14 00:00:00
Application Docs ID
75457
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021029s036_037_038lbl.pdf
Submission No
36
Submission Type
SUPPL
Appl No
021029
Application Docs Date
2023-09-14 00:00:00
Application Docs ID
75458
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021029s036_037_038lbl.pdf
Submission No
37
Submission Type
SUPPL
Appl No
021029
Application Docs Date
2023-09-14 00:00:00
Application Docs ID
75459
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021029s036_037_038lbl.pdf
Submission No
38
Submission Type
SUPPL
official application record
Appl No
021029
Appl Public Notes
Appl Type
NDA
Sponsor Name
MERCK SHARP DOHME
openfda application present
true
products
Active Ingredient
TEMOZOLOMIDE
Appl No
021029
Drug Name
TEMODAR
Form
CAPSULE;ORAL
Product No
001
Reference Drug
1
Reference Standard
0
Strength
5MG
marketing status
Discontinued
Active Ingredient
TEMOZOLOMIDE
Appl No
021029
Drug Name
TEMODAR
Form
CAPSULE;ORAL
Product No
002
Reference Drug
1
Reference Standard
0
Strength
20MG
marketing status
Discontinued
Active Ingredient
TEMOZOLOMIDE
Appl No
021029
Drug Name
TEMODAR
Form
CAPSULE;ORAL
Product No
003
Reference Drug
1
Reference Standard
0
Strength
100MG
marketing status
Discontinued
Active Ingredient
TEMOZOLOMIDE
Appl No
021029
Drug Name
TEMODAR
Form
CAPSULE;ORAL
Product No
004
Reference Drug
1
Reference Standard
0
Strength
250MG
marketing status
Discontinued
Active Ingredient
TEMOZOLOMIDE
Appl No
021029
Drug Name
TEMODAR
Form
CAPSULE;ORAL
Product No
005
Reference Drug
1
Reference Standard
0
Strength
140MG
marketing status
Discontinued
Active Ingredient
TEMOZOLOMIDE
Appl No
021029
Drug Name
TEMODAR
Form
CAPSULE;ORAL
Product No
006
Reference Drug
1
Reference Standard
0
Strength
180MG
marketing status
Discontinued
application number
NDA022277
payload
all indexed label documents
Appl No
022277
Application Docs Date
2011-02-09 00:00:00
Application Docs ID
17188
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021029s020,022277s004lbl.pdf
Submission No
4
Submission Type
SUPPL
Appl No
022277
Application Docs Date
2015-09-23 00:00:00
Application Docs ID
17189
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022277s009lbl.pdf
Submission No
9
Submission Type
SUPPL
Appl No
022277
Application Docs Date
2016-03-04 00:00:00
Application Docs ID
17190
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022277s011lbl.pdf
Submission No
11
Submission Type
SUPPL
Appl No
022277
Application Docs Date
2009-04-03 00:00:00
Application Docs ID
38487
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022277lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
022277
Application Docs Date
2010-04-28 00:00:00
Application Docs ID
38488
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022277s001lbl.pdf
Submission No
1
Submission Type
SUPPL
Appl No
022277
Application Docs Date
2011-06-07 00:00:00
Application Docs ID
38489
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021029s021,022277s005lbl.pdf
Submission No
5
Submission Type
SUPPL
Appl No
022277
Application Docs Date
2014-05-06 00:00:00
Application Docs ID
38490
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022277s007lbl.pdf
Submission No
7
Submission Type
SUPPL
Appl No
022277
Application Docs Date
2015-04-07 00:00:00
Application Docs ID
38491
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022277s008lbl.pdf
Submission No
8
Submission Type
SUPPL
Appl No
022277
Application Docs Date
2017-03-31 00:00:00
Application Docs ID
47801
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022277s010lbl.pdf
Submission No
10
Submission Type
SUPPL
Appl No
022277
Application Docs Date
2017-10-10 00:00:00
Application Docs ID
49994
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022277s012lbl.pdf
Submission No
12
Submission Type
SUPPL
Appl No
022277
Application Docs Date
2019-11-25 00:00:00
Application Docs ID
61045
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022277s013lbl.pdf
Submission No
13
Submission Type
SUPPL
Appl No
022277
Application Docs Date
2020-11-25 00:00:00
Application Docs ID
65318
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022277s014lbl.pdf
Submission No
14
Submission Type
SUPPL
all submission records
Appl No
022277
Review Priority
STANDARD
Submission Class Code ID
12
Submission No
1
Submission Status
AP
Submission Status Date
2009-02-27 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
022277
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
1
Submission Status
AP
Submission Status Date
2010-04-26 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022277
Review Priority
UNKNOWN
Submission Class Code ID
3
Submission No
4
Submission Status
AP
Submission Status Date
2011-02-04 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022277
Review Priority
UNKNOWN
Submission Class Code ID
3
Submission No
5
Submission Status
AP
Submission Status Date
2011-06-03 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022277
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
7
Submission Status
AP
Submission Status Date
2014-05-05 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022277
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
8
Submission Status
AP
Submission Status Date
2015-04-02 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022277
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
9
Submission Status
AP
Submission Status Date
2015-09-18 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022277
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
10
Submission Status
AP
Submission Status Date
2017-02-24 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022277
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
11
Submission Status
AP
Submission Status Date
2016-02-12 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022277
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
12
Submission Status
AP
Submission Status Date
2017-10-06 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022277
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
13
Submission Status
AP
Submission Status Date
2019-11-22 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
022277
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
14
Submission Status
AP
Submission Status Date
2020-11-20 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA022277
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=022277
has approved submission record
true
latest approved submission date
2023-09-14
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
022277
Application Docs Date
2023-09-14 00:00:00
Application Docs ID
75454
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022277s017_018_019lbl.pdf
Submission No
17
Submission Type
SUPPL
Appl No
022277
Application Docs Date
2023-09-14 00:00:00
Application Docs ID
75455
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022277s017_018_019lbl.pdf
Submission No
18
Submission Type
SUPPL
Appl No
022277
Application Docs Date
2023-09-14 00:00:00
Application Docs ID
75456
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022277s017_018_019lbl.pdf
Submission No
19
Submission Type
SUPPL
official application record
Appl No
022277
Appl Public Notes
Appl Type
NDA
Sponsor Name
MERCK SHARP DOHME
openfda application present
true
products
Active Ingredient
TEMOZOLOMIDE
Appl No
022277
Drug Name
TEMODAR
Form
POWDER;INTRAVENOUS
Product No
001
Reference Drug
1
Reference Standard
1
Strength
100MG/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

NDA021029
NDA022277

brand names

TEMODAR

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: 393
end exclusive: true
exact text: 1 INDICATIONS AND USAGE TEMODAR is an alkylating drug indicated for the treatment of adults with: Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. ( 1.1 ) Anaplastic astrocytoma. ( 1.2 ) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. ( 1.2 ) Treatment of adults with refractory anaplastic astrocytoma. ( 1.2 ) 1.1 Newly
label id: 40ceddc0-83a2-4b3b-8953-fd0078a41133
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 19209621db04e78f34d4358536c408301f894a869e10b67ccd417c19d1cbb759
start: 0

current approval status

not_reconciled

duplicate text group

dup-75edbb8ac57d3e686f05

extraction review status

automated_candidate_pending_source_review

generic names

TEMOZOLOMIDE

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not_inferred
span
end
757
end exclusive
true
exact text
refractory anaplastic astrocytoma
label id
40ceddc0-83a2-4b3b-8953-fd0078a41133
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
19209621db04e78f34d4358536c408301f894a869e10b67ccd417c19d1cbb759
start
724

regulatory links

candidate source span
end
758
end exclusive
true
exact text
1.2 Anaplastic Astrocytoma TEMODAR is indicated for the: adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma; treatment of adults with refractory anaplastic astrocytoma.
label id
40ceddc0-83a2-4b3b-8953-fd0078a41133
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
19209621db04e78f34d4358536c408301f894a869e10b67ccd417c19d1cbb759
start
568
fda indication exact
Adults with refractory anaplastic astrocytoma
fda source row index
117
fda source sha256
91f921503728c2afb0ec500d9c6034553e0b81d5af260a20c5478686c1127a7e
fda status record id
fda-aa-fecad5f173830107e328
interpretation
Source wording correspondence to a dated FDA status row; current approval not certified
match method
whole_indication_literal_normalized_substring
matching review status
source_comparison_only_clinical_review_pending
scope relationship
whole_fda_indication_text_present
source url
https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
status category
verified_clinical_benefit
status event date
2005-03-15
supporting anchor spans

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 758
end exclusive: true
exact text: 1.2 Anaplastic Astrocytoma TEMODAR is indicated for the: adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma; treatment of adults with refractory anaplastic astrocytoma.
label id: 40ceddc0-83a2-4b3b-8953-fd0078a41133
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 19209621db04e78f34d4358536c408301f894a869e10b67ccd417c19d1cbb759
start: 568

source url

https://api.fda.gov/drug/label.json?search=id%3A%2240ceddc0-83a2-4b3b-8953-fd0078a41133%22

spl effective date

2026-02-20

spl set id

046a9011-3911-4d3f-a15f-fbb56d5aad56

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

Read indication-specific status → · whole_fda_indication_text_present

Preserved source evidence · Not medical advice