Application 203482

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TEMAZEPAM	TEMAZEPAM	CAPSULE;ORAL	7.5MG	No	No
002	TEMAZEPAM	TEMAZEPAM	CAPSULE;ORAL	15MG	No	No
003	TEMAZEPAM	TEMAZEPAM	CAPSULE;ORAL	22.5MG	No	No
004	TEMAZEPAM	TEMAZEPAM	CAPSULE;ORAL	30MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203482-001	TEMAZEPAM	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2016-05-23
A203482-002	TEMAZEPAM	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2016-05-23
A203482-003	TEMAZEPAM	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2016-05-23
A203482-004	TEMAZEPAM	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2016-05-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A203482-001	AB
A203482-002	AB
A203482-003	AB
A203482-004	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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203482-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2016-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203482-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2016-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203482-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2016-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203482-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2016-05-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203482-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL		2016-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203482-002	TEMAZEPAM	15MG	CAPSULE / ORAL		2016-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203482-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL		2016-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203482-004	TEMAZEPAM	30MG	CAPSULE / ORAL		2016-05-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203482-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL		2016-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203482-002	TEMAZEPAM	15MG	CAPSULE / ORAL		2016-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203482-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL		2016-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203482-004	TEMAZEPAM	30MG	CAPSULE / ORAL		2016-05-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203482-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL		2016-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203482-002	TEMAZEPAM	15MG	CAPSULE / ORAL		2016-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203482-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL		2016-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203482-004	TEMAZEPAM	30MG	CAPSULE / ORAL		2016-05-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203482-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL		2016-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203482-002	TEMAZEPAM	15MG	CAPSULE / ORAL		2016-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203482-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL		2016-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203482-004	TEMAZEPAM	30MG	CAPSULE / ORAL		2016-05-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203482-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL		2016-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203482-002	TEMAZEPAM	15MG	CAPSULE / ORAL		2016-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203482-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL		2016-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203482-004	TEMAZEPAM	30MG	CAPSULE / ORAL		2016-05-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203482-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL		2016-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203482-002	TEMAZEPAM	15MG	CAPSULE / ORAL		2016-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203482-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL		2016-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203482-004	TEMAZEPAM	30MG	CAPSULE / ORAL		2016-05-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203482-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2016-05-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203482-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2016-05-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203482-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2016-05-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203482-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2016-05-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203482-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL		2016-05-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203482-002	TEMAZEPAM	15MG	CAPSULE / ORAL		2016-05-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203482-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL		2016-05-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203482-004	TEMAZEPAM	30MG	CAPSULE / ORAL		2016-05-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203482-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2016-05-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203482-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2016-05-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203482-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2016-05-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203482-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2016-05-23	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 136 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203482-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203482-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203482-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203482-004	AB	1	`011fe1cb6892…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203482-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203482-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203482-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203482-004	AB	1	`5bbf6a4d5a75…`
2024-10-29 15:01 UTC	2024-10	A203482-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203482-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203482-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203482-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203482-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203482-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203482-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203482-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203482-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203482-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203482-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203482-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203482-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203482-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203482-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203482-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203482-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203482-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203482-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203482-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203482-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203482-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203482-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203482-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203482-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203482-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203482-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203482-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203482-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203482-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203482-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203482-004	AB	1	`4b0b4de00fa7…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Temazepam	TEMAZEPAM	Bryant Ranch Prepack	066e25b2-8a1b-4b08-b585-ce36753bf104	2024-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203482 application number: ANDA203482 ndc (product): 71335-1901
Temazepam	TEMAZEPAM	Amneal Pharmaceuticals LLC	be68c6e0-17ad-40fe-9bc1-58abe24b53f6	2024-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203482 application number: ANDA203482 ndc (product): 65162-557 ndc (product): 65162-583 ndc (product): 65162-556 ndc (product): 65162-584
Temazepam	TEMAZEPAM	Amneal Pharmaceuticals of New York LLC	6248295e-8176-48f8-8e9d-bba6deacaf0d	2024-02-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203482 application number: ANDA203482

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65162-556	Temazepam	Temazepam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-556	Temazepam	Temazepam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-556	Temazepam	Temazepam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-556	Temazepam	Temazepam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-557	Temazepam	Temazepam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-557	Temazepam	Temazepam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-557	Temazepam	Temazepam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-557	Temazepam	Temazepam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-583	Temazepam	Temazepam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-583	Temazepam	Temazepam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-583	Temazepam	Temazepam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-583	Temazepam	Temazepam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-584	Temazepam	Temazepam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-584	Temazepam	Temazepam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-584	Temazepam	Temazepam	Amneal Pharmaceuticals LLC	ANDA	Current
65162-584	Temazepam	Temazepam	Amneal Pharmaceuticals LLC	ANDA	Current
68788-6904	Temazepam	Temazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-3227	Temazepam	Temazepam	REMEDYREPACK INC.	ANDA	Current
70518-3229	Temazepam	Temazepam	REMEDYREPACK INC.	ANDA	Current
70518-3229	Temazepam	Temazepam	REMEDYREPACK INC.	ANDA	Current
71335-1901	Temazepam	Temazepam	Bryant Ranch Prepack	ANDA	Current
71335-1901	Temazepam	Temazepam	Bryant Ranch Prepack	ANDA	Current