Application 203691

Type: ANDA
Sponsor: AMNEAL PHARMS

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 42.

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	TE codes	RLD / RS	Approval date
A203691-001	TEMOZOLOMIDE	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB		2015-05-08
A203691-002	TEMOZOLOMIDE	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB		2015-05-08
A203691-003	TEMOZOLOMIDE	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB		2015-05-08
A203691-004	TEMOZOLOMIDE	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB		2015-05-08
A203691-005	TEMOZOLOMIDE	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB		2015-05-08
A203691-006	TEMOZOLOMIDE	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	RS	2015-05-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A203691-001	AB
A203691-002	AB
A203691-003	AB
A203691-004	AB
A203691-005	AB
A203691-006	AB

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 7 · 252 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A203691-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB		2015-05-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203691-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB		2015-05-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203691-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB		2015-05-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203691-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB		2015-05-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203691-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB		2015-05-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203691-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	RS	2015-05-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203691-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB		2015-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203691-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB		2015-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203691-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB		2015-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203691-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB		2015-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203691-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB		2015-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203691-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	RS	2015-05-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203691-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB		2015-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203691-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB		2015-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203691-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB		2015-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203691-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB		2015-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203691-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB		2015-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203691-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	RS	2015-05-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203691-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB		2015-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203691-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB		2015-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203691-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB		2015-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203691-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB		2015-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203691-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB		2015-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203691-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	RS	2015-05-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203691-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB		2015-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203691-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB		2015-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203691-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB		2015-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203691-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB		2015-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203691-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB		2015-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203691-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	RS	2015-05-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203691-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB		2015-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203691-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB		2015-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203691-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB		2015-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203691-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB		2015-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203691-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB		2015-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203691-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	RS	2015-05-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203691-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB		2015-05-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203691-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB		2015-05-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203691-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB		2015-05-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203691-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB		2015-05-08	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 252 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203691-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203691-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203691-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203691-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203691-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203691-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203691-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203691-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203691-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203691-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203691-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203691-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203691-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203691-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203691-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203691-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203691-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203691-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203691-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203691-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203691-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203691-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203691-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203691-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203691-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203691-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203691-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203691-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203691-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203691-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203691-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203691-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203691-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203691-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203691-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203691-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203691-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203691-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203691-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203691-004	AB	1	`03ed91905a0d…`

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	Amneal Pharmaceuticals LLC	6c8529ec-8936-4fec-a1a5-2b285c7e4859	2024-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203691 application number: ANDA203691 ndc (product): 65162-801 ndc (product): 65162-803 ndc (product): 65162-805 ndc (product): 65162-802 ndc (product): 65162-806 ndc (product): 65162-804

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50268-761	Temozolomide	Temozolomide	AvPAK	ANDA	Current
50268-761	Temozolomide	Temozolomide	AvPAK	ANDA	Current
50268-761	Temozolomide	Temozolomide	AvPAK	ANDA	Current
50268-762	Temozolomide	Temozolomide	AvPAK	ANDA	Current
50268-762	Temozolomide	Temozolomide	AvPAK	ANDA	Current
50268-762	Temozolomide	Temozolomide	AvPAK	ANDA	Current
50268-763	Temozolomide	Temozolomide	AvPAK	ANDA	Current
65162-801	Temozolomide	Temozolomide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-801	Temozolomide	Temozolomide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-801	Temozolomide	Temozolomide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-801	Temozolomide	Temozolomide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-801	Temozolomide	Temozolomide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-802	Temozolomide	Temozolomide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-802	Temozolomide	Temozolomide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-802	Temozolomide	Temozolomide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-802	Temozolomide	Temozolomide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-802	Temozolomide	Temozolomide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-803	Temozolomide	Temozolomide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-803	Temozolomide	Temozolomide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-803	Temozolomide	Temozolomide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-803	Temozolomide	Temozolomide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-803	Temozolomide	Temozolomide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-804	Temozolomide	Temozolomide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-804	Temozolomide	Temozolomide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-804	Temozolomide	Temozolomide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-804	Temozolomide	Temozolomide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-804	Temozolomide	Temozolomide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-805	Temozolomide	Temozolomide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-805	Temozolomide	Temozolomide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-805	Temozolomide	Temozolomide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-805	Temozolomide	Temozolomide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-805	Temozolomide	Temozolomide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-806	Temozolomide	Temozolomide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-806	Temozolomide	Temozolomide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-806	Temozolomide	Temozolomide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-806	Temozolomide	Temozolomide	Amneal Pharmaceuticals LLC	ANDA	Current
65162-806	Temozolomide	Temozolomide	Amneal Pharmaceuticals LLC	ANDA	Current