Application 213328

Type: ANDA
Sponsor: NIVAGEN PHARMS INC

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	180MG	No	No
006	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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A213328-001	TEMOZOLOMIDE	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2021-11-23
A213328-002	TEMOZOLOMIDE	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2021-11-23
A213328-003	TEMOZOLOMIDE	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2021-11-23
A213328-004	TEMOZOLOMIDE	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2021-11-23
A213328-005	TEMOZOLOMIDE	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	2021-11-23
A213328-006	TEMOZOLOMIDE	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	2021-11-23

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 · 210 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	A213328-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2021-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213328-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2021-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213328-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2021-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213328-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2021-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213328-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	2021-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213328-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	2021-11-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213328-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2021-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213328-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2021-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213328-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2021-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213328-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2021-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213328-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	2021-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213328-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	2021-11-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213328-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2021-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213328-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2021-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213328-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2021-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213328-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2021-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213328-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	2021-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213328-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	2021-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213328-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2021-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213328-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2021-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213328-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2021-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213328-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2021-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213328-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	2021-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213328-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	2021-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213328-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2021-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213328-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2021-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213328-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2021-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213328-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2021-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213328-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	2021-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213328-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	2021-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213328-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2021-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213328-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2021-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213328-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2021-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213328-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2021-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213328-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	2021-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213328-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	2021-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213328-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2021-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213328-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2021-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213328-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2021-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213328-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2021-11-23	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 4 · 138 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A213328-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A213328-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A213328-003	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A213328-004	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A213328-005	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A213328-006	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213328-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A213328-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A213328-003	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A213328-004	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A213328-005	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A213328-006	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213328-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213328-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213328-003	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213328-004	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213328-005	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213328-006	AB	1	`cb3db0bc1861…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
temozolomide	TEMOZOLOMIDE	Nivagen Pharmaceuticals, Inc.	27e5a781-e4f2-4489-9def-7971d0b86d9c	2021-11-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213328 application number: ANDA213328 ndc (product): 75834-144 ndc (product): 75834-142 ndc (product): 75834-146 ndc (product): 75834-145 ndc (product): 75834-143 ndc (product): 75834-132

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
75834-132	temozolomide	temozolomide	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-142	temozolomide	temozolomide	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-143	temozolomide	temozolomide	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-144	temozolomide	temozolomide	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-145	temozolomide	temozolomide	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-146	temozolomide	temozolomide	Nivagen Pharmaceuticals, Inc.	ANDA	Current