Application 203959

Type: ANDA
Sponsor: WATSON LABS TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TEMOZOLOMIDE	TEMOZOLOMIDE	CAPSULE;ORAL	5MG	No	No
002	TEMOZOLOMIDE	TEMOZOLOMIDE	CAPSULE;ORAL	20MG	No	No
003	TEMOZOLOMIDE	TEMOZOLOMIDE	CAPSULE;ORAL	100MG	No	No
004	TEMOZOLOMIDE	TEMOZOLOMIDE	CAPSULE;ORAL	140MG	No	No
005	TEMOZOLOMIDE	TEMOZOLOMIDE	CAPSULE;ORAL	250MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A203959-001	TEMOZOLOMIDE	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2017-04-18
A203959-002	TEMOZOLOMIDE	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2017-04-18
A203959-003	TEMOZOLOMIDE	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2017-04-18
A203959-004	TEMOZOLOMIDE	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2017-04-18
A203959-005	TEMOZOLOMIDE	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	2017-04-18

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.

Product history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A203959-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2017-04-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203959-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2017-04-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203959-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2017-04-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203959-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2017-04-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203959-005	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	2017-04-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203959-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2017-04-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203959-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2017-04-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203959-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2017-04-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203959-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2017-04-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203959-005	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	2017-04-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203959-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2017-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203959-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2017-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203959-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2017-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203959-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2017-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203959-005	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	2017-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203959-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2017-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203959-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2017-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203959-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2017-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203959-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2017-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203959-005	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	2017-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203959-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2017-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203959-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2017-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203959-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2017-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203959-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2017-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203959-005	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	2017-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203959-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2017-04-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203959-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2017-04-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203959-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2017-04-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203959-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2017-04-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203959-005	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	2017-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203959-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2017-04-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203959-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2017-04-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203959-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2017-04-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203959-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2017-04-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203959-005	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	2017-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203959-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2017-04-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203959-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2017-04-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203959-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2017-04-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203959-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2017-04-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203959-005	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	2017-04-18	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A203959-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203959-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203959-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203959-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203959-005	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A203959-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A203959-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A203959-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A203959-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A203959-005	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203959-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203959-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203959-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203959-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203959-005	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203959-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203959-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203959-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203959-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203959-005	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203959-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203959-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203959-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203959-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203959-005	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203959-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203959-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203959-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203959-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203959-005	AB	1	`ea99ee380514…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Temozolomide	TEMOZOLOMIDE	OPKO Pharmaceuticals, LLC	9dff10ec-6a55-47b6-a458-b7c39e32dc55	2026-08-27	Warnings, Adverse reactions	Name fallback brand name: Temozolomide generic name: TEMOZOLOMIDE
Temozolomide	TEMOZOLOMIDE	OPKO Pharmaceuticals, LLC	f6d762ea-fff0-43e8-b67d-bef19e883dd8	2026-08-27	Warnings, Adverse reactions	Name fallback brand name: Temozolomide generic name: TEMOZOLOMIDE
Temozolomide	TEMOZOLOMIDE	OPKO Pharmaceuticals, LLC	f743f7e0-74cf-47e5-bf21-f2b75d2596dc	2026-08-27	Warnings, Adverse reactions	Name fallback brand name: Temozolomide generic name: TEMOZOLOMIDE
Temozolomide	TEMOZOLOMIDE	OPKO Pharmaceuticals, LLC	b3f69c67-db30-4266-8075-9b18c71c9fc1	2026-08-27	Warnings, Adverse reactions	Name fallback brand name: Temozolomide generic name: TEMOZOLOMIDE
Temozolomide	TEMOZOLOMIDE	CivicaScript LLC	56245d21-4a42-471e-bbdc-80b129336e2f	2026-08-11	Warnings, Adverse reactions	Name fallback brand name: Temozolomide generic name: TEMOZOLOMIDE
Temozolomide	TEMOZOLOMIDE	Bryant Ranch Prepack	79766855-2533-43b1-b60e-1e9daecadad5	2026-06-09	Warnings, Adverse reactions	Name fallback brand name: Temozolomide generic name: TEMOZOLOMIDE
Temozolomide	TEMOZOLOMIDE	Bryant Ranch Prepack	021b97cc-a76f-44b6-b7be-670d2ae83690	2026-06-09	Warnings, Adverse reactions	Name fallback brand name: Temozolomide generic name: TEMOZOLOMIDE
Temozolomide	TEMOZOLOMIDE	Bryant Ranch Prepack	c0f2077c-48e6-452e-9f88-e1f2c89df0a2	2026-06-09	Warnings, Adverse reactions	Name fallback brand name: Temozolomide generic name: TEMOZOLOMIDE
Temozolomide	TEMOZOLOMIDE	Bryant Ranch Prepack	38f17780-8037-44a0-9e84-b7150c9bde12	2026-06-09	Warnings, Adverse reactions	Name fallback brand name: Temozolomide generic name: TEMOZOLOMIDE
Temozolomide	TEMOZOLOMIDE	Bryant Ranch Prepack	6eb0bd33-582f-43a6-a607-e72b4390c6d3	2026-06-09	Warnings, Adverse reactions	Name fallback brand name: Temozolomide generic name: TEMOZOLOMIDE
Temozolomide	TEMOZOLOMIDE	Bryant Ranch Prepack	a147b361-262c-49c6-9b8e-7e454f755721	2026-06-09	Warnings, Adverse reactions	Name fallback brand name: Temozolomide generic name: TEMOZOLOMIDE
TEMODAR	TEMOZOLOMIDE	Merck Sharp & Dohme LLC	046a9011-3911-4d3f-a15f-fbb56d5aad56	2026-02-20	Warnings, Adverse reactions	Name fallback generic name: TEMOZOLOMIDE
Temozolomide	TEMOZOLOMIDE	Sun Pharmaceutical Industries, Inc.	c1e05c21-a411-4493-80de-ede373632475	2025-11-14	Warnings, Adverse reactions	Name fallback brand name: Temozolomide generic name: TEMOZOLOMIDE
Temozolomide	TEMOZOLOMIDE	Accord Healthcare Inc.	2d599ccf-8e63-4ff1-aa52-4809744ea97a	2025-05-23	Warnings, Adverse reactions	Name fallback brand name: Temozolomide generic name: TEMOZOLOMIDE
Temozolomide	TEMOZOLOMIDE	Ascend Laboratories, LLC	33d67bce-38ae-45fc-a858-d51167b0ecfd	2025-01-09	Warnings, Adverse reactions	Name fallback brand name: Temozolomide generic name: TEMOZOLOMIDE
Temozolomide	TEMOZOLOMIDE	Devatis, Inc.	6b263fe0-5f06-4889-bf14-4aa185470810	2024-11-30	Warnings, Adverse reactions	Name fallback brand name: Temozolomide generic name: TEMOZOLOMIDE
TEMOZOLOMIDE	TEMOZOLOMIDE	Camber Pharmaceuticals, Inc.	78c12889-c837-40c1-8f85-4d048008ad29	2024-10-19	Warnings, Adverse reactions	Name fallback brand name: TEMOZOLOMIDE generic name: TEMOZOLOMIDE
TEMOZOLOMIDE	TEMOZOLOMIDE	Rising Pharma Holdings, Inc.	70996a9d-4a4f-4ed1-ab07-130486aa14ab	2024-07-25	Warnings, Adverse reactions	Name fallback brand name: TEMOZOLOMIDE generic name: TEMOZOLOMIDE
Temozolomide	TEMOZOLOMIDE	Amneal Pharmaceuticals LLC	6c8529ec-8936-4fec-a1a5-2b285c7e4859	2024-02-17	Warnings, Adverse reactions	Name fallback brand name: Temozolomide generic name: TEMOZOLOMIDE
temozolomide	TEMOZOLOMIDE	Nivagen Pharmaceuticals, Inc.	27e5a781-e4f2-4489-9def-7971d0b86d9c	2021-11-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: temozolomide generic name: TEMOZOLOMIDE