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 1 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	ac08a51c-6c54-40da-9626-a4c82f337a3a	2026-09-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: temazepam generic name: TEMAZEPAM
temazepam	TEMAZEPAM	Bryant Ranch Prepack	5d83e474-0932-49ae-ad92-ca278cd5f1d5	2026-09-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: temazepam generic name: TEMAZEPAM
temazepam	TEMAZEPAM	Bryant Ranch Prepack	1c08d30d-7c27-a09a-5240-7050771d5cc7	2026-09-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: temazepam generic name: TEMAZEPAM
Temazepam	TEMAZEPAM	Major Pharmaceuticals	2c4f564d-d349-4f9b-b3f4-f3f0d9706a4d	2026-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Temazepam generic name: TEMAZEPAM
temazepam	TEMAZEPAM	PD-Rx Pharmaceuticals, Inc.	62379cd5-a314-43eb-a1ee-33997623bfa3	2026-08-10	Warnings, Adverse reactions	Name fallback brand name: temazepam generic name: TEMAZEPAM
temazepam	TEMAZEPAM	Ascend Laboratories, LLC	8f54731f-c5b7-492c-acb0-444c5fbb7029	2026-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: temazepam generic name: TEMAZEPAM
Temazepam	TEMAZEPAM	REMEDYREPACK INC.	85919240-0bac-4ed9-97aa-f1aa29be7ffa	2026-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Temazepam generic name: TEMAZEPAM
RESTORIL	TEMAZEPAM	SpecGx LLC	bc56f7fd-1aaf-48ff-8aa7-d467e59e1015	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TEMAZEPAM
TEMAZEPAM	TEMAZEPAM	SpecGx LLC	c9bc61b4-a579-4003-98da-b6f6e381c150	2026-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TEMAZEPAM generic name: TEMAZEPAM
Temazepam	TEMAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	4a2ab77d-8b80-7eb1-e063-6394a90a1469	2026-02-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Temazepam generic name: TEMAZEPAM
temazepam	TEMAZEPAM	Preferred Pharmaceuticals Inc.	7e3fd8fe-fb8a-4577-b540-0e3fefe63627	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: temazepam generic name: TEMAZEPAM
Temazepam	TEMAZEPAM	American Health Packaging	a3f06243-fa03-4cbd-951a-144ec43dcdfd	2025-11-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Temazepam generic name: TEMAZEPAM
temazepam	TEMAZEPAM	Bryant Ranch Prepack	4fe8192a-0f65-4958-8b6d-e87b9fae9eb5	2025-11-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: temazepam generic name: TEMAZEPAM
temazepam	TEMAZEPAM	Bryant Ranch Prepack	bbb6e233-dc6b-43a7-8203-d91421d89921	2025-11-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: temazepam generic name: TEMAZEPAM
temazepam	TEMAZEPAM	Bryant Ranch Prepack	a1f0ed55-9401-4afe-ba98-1ca115ba86b5	2025-11-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: temazepam generic name: TEMAZEPAM
temazepam	TEMAZEPAM	A-S Medication Solutions	19b2711e-587a-47d2-ab62-d564e7b87195	2025-10-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: temazepam generic name: TEMAZEPAM
temazepam	TEMAZEPAM	PD-Rx Pharmaceuticals, Inc.	45ef5e9c-f381-48d3-895d-e1d29be856ac	2025-10-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: temazepam generic name: TEMAZEPAM
TEMAZEPAM	TEMAZEPAM	PD-Rx Pharmaceuticals, Inc.	97afda58-4daf-4192-bd87-3ccbb000ee52	2025-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TEMAZEPAM generic name: TEMAZEPAM
temazepam	TEMAZEPAM	Bryant Ranch Prepack	dadc2f66-7fa5-4be4-a9d0-d96e5836f550	2025-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: temazepam generic name: TEMAZEPAM
temazepam	TEMAZEPAM	Asclemed USA, Inc.	254a0273-c0f3-4d2d-b18e-4ab51ba4bc50	2025-10-08	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.