TriangleSTATUS · fda-aa-fecad5f173830107e328
Temodar (temozolomide)
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This status concerns only the indication wording below. It must not be applied to other uses of the same drug. It is not reconciled against the current label.
Exact indication
Adults with refractory anaplastic astrocytoma
- Source status category
- verified clinical benefit
- Event date
- 2005-03-15
- Meaning of this date
- FDA table traditional approval date
- accelerated approval date
- 1999-08-11
- accelerated approval date source text
- 8/11/1999
- brand name hint
- Temodar
- date change comparison status
- no_previous_normalized_snapshot_supplied
- date change from prior snapshot
- Source null
- drug name exact
- Temodar (temozolomide)
- generic name hint
- temozolomide
- id
- fda-aa-fecad5f173830107e328
- indication exact
- Adults with refractory anaplastic astrocytoma
- original projected completion source text
- Source null
- post marketing requirement exact
- Source null
- record type
- fda_accelerated_approval_status_row
- related fda urls
- source cells exact
- links
- text
- Temodar (temozolomide)
- links
- text
- Adults with refractory anaplastic astrocytoma
- links
- text
- 8/11/1999
- links
- text
- 3/15/2005
- source provenance
- bytes
- 74315
- effective url
- https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
- file
- /private/tmp/cancer-full-research/indications/raw/accelerated-verified.html
- http status
- 200
- requested url
- https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
- retrieved at
- 2026-09-09T23:35:16.058704+00:00
- sha256
- 91f921503728c2afb0ec500d9c6034553e0b81d5af260a20c5478686c1127a7e
- source page date Modified text
- Wed, 07/15/2026 - 00:00
- source page date Published text
- Wed, 07/15/2026 - 07:11
- source row index
- 117
- source table headers
- Drug Name
- Accelerated Approval (AA) Indication
- Accelerated Approval Date
- Traditional Approval Date
- source table index
- 0
- status applies to
- This exact indication and regimen, not every use of this drug
- status category
- verified_clinical_benefit
- status event date
- 2005-03-15
- status event date meaning
- FDA table traditional approval date
- traditional approval date
- 2005-03-15
- verification flags
- verification status
- official_fda_status_table_extracted_indication_matching_not_clinically_reviewed
- withdrawal date
- Source null
Source correspondence records
- matching
- drug name exact
- Temodar (temozolomide)
- fda status record id
- fda-aa-fecad5f173830107e328
- indication exact
- Adults with refractory anaplastic astrocytoma
- match status
- source_correspondence_found_clinical_review_pending
- matched candidate ids
- ind-span-d808b02005bbd9f9eef9
- ind-span-2400cfa757e307d1aff6
- source provenance
- bytes
- 74315
- effective url
- https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
- file
- /private/tmp/cancer-full-research/indications/raw/accelerated-verified.html
- http status
- 200
- requested url
- https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
- retrieved at
- 2026-09-09T23:35:16.058704+00:00
- sha256
- 91f921503728c2afb0ec500d9c6034553e0b81d5af260a20c5478686c1127a7e
- source page date Modified text
- Wed, 07/15/2026 - 00:00
- source page date Published text
- Wed, 07/15/2026 - 07:11
- status category
- verified_clinical_benefit
- unmatched meaning
- Source null
- links
- package id
- fda-label-library-8184721b7b3bb86692f8276c
- correspondence id
- correspondence-35f47a7d32a17c80503943ff
- span id
- ind-span-2400cfa757e307d1aff6
- status id
- fda-aa-fecad5f173830107e328
- match method
- whole_indication_literal_normalized_substring
- scope relationship
- whole_fda_indication_text_present
- matching review status
- source_comparison_only_clinical_review_pending
- payload
- 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
- status category
- verified_clinical_benefit
- status event date
- 2005-03-15
- supporting anchor spans
- package id
- fda-label-library-8184721b7b3bb86692f8276c
- correspondence id
- correspondence-f567112981e6eda6167c5ea3
- span id
- ind-span-d808b02005bbd9f9eef9
- status id
- fda-aa-fecad5f173830107e328
- match method
- whole_indication_literal_normalized_substring
- scope relationship
- whole_fda_indication_text_present
- matching review status
- source_comparison_only_clinical_review_pending
- payload
- candidate source span
- end
- 375
- end exclusive
- true
- exact text
- ( 1.2 ) 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
- 308
- 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
- status category
- verified_clinical_benefit
- status event date
- 2005-03-15
- supporting anchor spans
Preserved source evidence · Not medical advice