Application 217875

Type: ANDA
Sponsor: ALKEM LABS LTD

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 43.

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
A217875-001	TEMAZEPAM	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2023-08-24
A217875-002	TEMAZEPAM	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2023-08-24
A217875-003	TEMAZEPAM	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2023-08-24
A217875-004	TEMAZEPAM	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2023-08-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217875-001	AB
A217875-002	AB
A217875-003	AB
A217875-004	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 3 · 88 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
2026-09-14 22:38:34	2026-08	A217875-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2023-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217875-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2023-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217875-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2023-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217875-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2023-08-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217875-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2023-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217875-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2023-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217875-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2023-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217875-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2023-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217875-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2023-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217875-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2023-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217875-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2023-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217875-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2023-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217875-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2023-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217875-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2023-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217875-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2023-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217875-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2023-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217875-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2023-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217875-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2023-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217875-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2023-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217875-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2023-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217875-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2023-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217875-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2023-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217875-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2023-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217875-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2023-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217875-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2023-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217875-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2023-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217875-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2023-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217875-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2023-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217875-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2023-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217875-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2023-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217875-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2023-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217875-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2023-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217875-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2023-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217875-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2023-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217875-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2023-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217875-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2023-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217875-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2023-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217875-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2023-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217875-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2023-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217875-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2023-08-24	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A217875-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217875-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217875-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217875-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217875-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217875-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217875-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217875-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217875-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217875-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217875-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217875-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217875-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217875-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217875-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217875-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217875-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217875-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217875-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217875-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217875-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217875-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217875-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217875-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217875-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217875-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217875-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217875-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217875-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217875-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217875-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217875-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217875-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217875-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217875-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217875-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217875-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217875-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217875-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217875-004	AB	1	`5bbf6a4d5a75…`

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 3 of 3 · 55 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
temazepam	TEMAZEPAM	Bryant Ranch Prepack	147a51d7-2f8d-43e8-b0ed-a79a2cdfc0a9	2024-03-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: temazepam generic name: TEMAZEPAM
Temazepam	TEMAZEPAM	Amneal Pharmaceuticals of New York LLC	6248295e-8176-48f8-8e9d-bba6deacaf0d	2024-02-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Temazepam generic name: TEMAZEPAM
temazepam	TEMAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	b2422ca0-2f06-419f-aa0e-88c556b62399	2024-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: temazepam generic name: TEMAZEPAM
temazepam	TEMAZEPAM	Bryant Ranch Prepack	1e37d59b-b8be-46ef-8706-fffd563a8c15	2024-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: temazepam generic name: TEMAZEPAM
temazepam	TEMAZEPAM	Bryant Ranch Prepack	0e752dda-f00f-4123-b59f-aa911b897a5a	2023-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: temazepam generic name: TEMAZEPAM
Temazepam	TEMAZEPAM	Bryant Ranch Prepack	74a3db09-94d0-45e1-8c68-da7ca49d3d59	2023-11-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Temazepam generic name: TEMAZEPAM
temazepam	TEMAZEPAM	Bryant Ranch Prepack	4ae0c582-8b0f-42f9-9b05-f7e1698c5183	2023-11-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: temazepam generic name: TEMAZEPAM
temazepam	TEMAZEPAM	Bryant Ranch Prepack	5dc0c671-3cd8-4e75-9e76-19c1c17b30b2	2023-11-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: temazepam generic name: TEMAZEPAM
temazepam	TEMAZEPAM	Proficient Rx LP	904b8986-24da-48eb-bb0a-33d41b4eb005	2023-06-01	Warnings, Adverse reactions	Name fallback brand name: temazepam generic name: TEMAZEPAM
Temazepam	TEMAZEPAM	Alembic Pharmaceuticals Inc.	93b1be7f-ec41-46bb-a258-56cb459e2c92	2023-02-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Temazepam generic name: TEMAZEPAM
Temazepam	TEMAZEPAM	Alembic Pharmaceuticals Limited	db839409-8e95-41d3-804e-dcd5d11f4934	2023-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Temazepam generic name: TEMAZEPAM
temazepam	TEMAZEPAM	Proficient Rx LP	ccf04879-3ad5-4fc3-89f5-879c97887017	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: temazepam generic name: TEMAZEPAM
temazepam	TEMAZEPAM	Proficient Rx LP	5aaf8c99-cd58-47fc-8bf5-1039a6315ca5	2021-01-01	Warnings, Adverse reactions	Name fallback brand name: temazepam generic name: TEMAZEPAM
Temazepam	TEMAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	2461dfbd-5704-42f4-bde7-d1461811d898	2019-05-17	Warnings, Adverse reactions	Name fallback brand name: Temazepam generic name: TEMAZEPAM
TEMAZEPAM	TEMAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	405b1ee2-777b-4fd3-b4ee-bd2aacbe1dc1	2019-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TEMAZEPAM generic name: TEMAZEPAM

Reported adverse events (FAERS/openFDA)#

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