FDA.reportPublic FDA data

Application 203959

Type
ANDA
Sponsor
WATSON LABS TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TEMOZOLOMIDETEMOZOLOMIDECAPSULE;ORAL5MGNoNo
002TEMOZOLOMIDETEMOZOLOMIDECAPSULE;ORAL20MGNoNo
003TEMOZOLOMIDETEMOZOLOMIDECAPSULE;ORAL100MGNoNo
004TEMOZOLOMIDETEMOZOLOMIDECAPSULE;ORAL140MGNoNo
005TEMOZOLOMIDETEMOZOLOMIDECAPSULE;ORAL250MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203959-001TEMOZOLOMIDETEMOZOLOMIDE5MGCAPSULE / ORAL2017-04-18
A203959-002TEMOZOLOMIDETEMOZOLOMIDE20MGCAPSULE / ORAL2017-04-18
A203959-003TEMOZOLOMIDETEMOZOLOMIDE100MGCAPSULE / ORAL2017-04-18
A203959-004TEMOZOLOMIDETEMOZOLOMIDE140MGCAPSULE / ORAL2017-04-18
A203959-005TEMOZOLOMIDETEMOZOLOMIDE250MGCAPSULE / ORAL2017-04-18

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A203959-001TEMOZOLOMIDE5MGCAPSULE / ORAL2017-04-18a50c72e98297…
2026-08-01 22:54:322026-06A203959-002TEMOZOLOMIDE20MGCAPSULE / ORAL2017-04-18a50c72e98297…
2026-08-01 22:54:322026-06A203959-003TEMOZOLOMIDE100MGCAPSULE / ORAL2017-04-18a50c72e98297…
2026-08-01 22:54:322026-06A203959-004TEMOZOLOMIDE140MGCAPSULE / ORAL2017-04-18a50c72e98297…
2026-08-01 22:54:322026-06A203959-005TEMOZOLOMIDE250MGCAPSULE / ORAL2017-04-18a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TemozolomideTEMOZOLOMIDEOPKO Pharmaceuticals, LLC9dff10ec-6a55-47b6-a458-b7c39e32dc552026-07-27Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
TemozolomideTEMOZOLOMIDEOPKO Pharmaceuticals, LLCf6d762ea-fff0-43e8-b67d-bef19e883dd82026-07-27Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
TemozolomideTEMOZOLOMIDEOPKO Pharmaceuticals, LLCf743f7e0-74cf-47e5-bf21-f2b75d2596dc2026-07-27Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
TemozolomideTEMOZOLOMIDEOPKO Pharmaceuticals, LLCb3f69c67-db30-4266-8075-9b18c71c9fc12026-07-27Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
TemozolomideTEMOZOLOMIDEBryant Ranch Prepack79766855-2533-43b1-b60e-1e9daecadad52026-06-09Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
TemozolomideTEMOZOLOMIDEBryant Ranch Prepack021b97cc-a76f-44b6-b7be-670d2ae836902026-06-09Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
TemozolomideTEMOZOLOMIDEBryant Ranch Prepackc0f2077c-48e6-452e-9f88-e1f2c89df0a22026-06-09Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
TemozolomideTEMOZOLOMIDEBryant Ranch Prepack38f17780-8037-44a0-9e84-b7150c9bde122026-06-09Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
TemozolomideTEMOZOLOMIDEBryant Ranch Prepack6eb0bd33-582f-43a6-a607-e72b4390c6d32026-06-09Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
TemozolomideTEMOZOLOMIDEBryant Ranch Prepacka147b361-262c-49c6-9b8e-7e454f7557212026-06-09Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
TemozolomideTEMOZOLOMIDECivicaScript LLC56245d21-4a42-471e-bbdc-80b129336e2f2026-04-28Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
TEMODARTEMOZOLOMIDEMerck Sharp & Dohme LLC046a9011-3911-4d3f-a15f-fbb56d5aad562026-02-20Warnings, Adverse reactionsName fallback
generic name: TEMOZOLOMIDE
TemozolomideTEMOZOLOMIDESun Pharmaceutical Industries, Inc.c1e05c21-a411-4493-80de-ede3736324752025-11-14Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
TemozolomideTEMOZOLOMIDEAccord Healthcare Inc.2d599ccf-8e63-4ff1-aa52-4809744ea97a2025-05-23Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
TemozolomideTEMOZOLOMIDEAscend Laboratories, LLC33d67bce-38ae-45fc-a858-d51167b0ecfd2025-01-09Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
TemozolomideTEMOZOLOMIDEDevatis, Inc.6b263fe0-5f06-4889-bf14-4aa1854708102024-11-30Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
TEMOZOLOMIDETEMOZOLOMIDECamber Pharmaceuticals, Inc.78c12889-c837-40c1-8f85-4d048008ad292024-10-19Warnings, Adverse reactionsName fallback
brand name: TEMOZOLOMIDE
generic name: TEMOZOLOMIDE
TEMOZOLOMIDETEMOZOLOMIDERising Pharma Holdings, Inc.70996a9d-4a4f-4ed1-ab07-130486aa14ab2024-07-25Warnings, Adverse reactionsName fallback
brand name: TEMOZOLOMIDE
generic name: TEMOZOLOMIDE
TemozolomideTEMOZOLOMIDEAmneal Pharmaceuticals LLC6c8529ec-8936-4fec-a1a5-2b285c7e48592024-02-17Warnings, Adverse reactionsName fallback
brand name: Temozolomide
generic name: TEMOZOLOMIDE
temozolomideTEMOZOLOMIDENivagen Pharmaceuticals, Inc.27e5a781-e4f2-4489-9def-7971d0b86d9c2021-11-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: temozolomide
generic name: TEMOZOLOMIDE