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 2 of 3 · 55 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Temazepam	TEMAZEPAM	Preferred Pharmaceuticals Inc.	cbe5bd6a-f36a-4557-82d8-ef4e49d310e9	2025-09-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Temazepam generic name: TEMAZEPAM
temazepam	TEMAZEPAM	Preferred Pharmaceuticals Inc.	42b81d6f-8171-4cd0-ab79-f031a8254d65	2025-09-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: temazepam generic name: TEMAZEPAM
Temazepam	TEMAZEPAM	Bryant Ranch Prepack	38afa73c-7c87-440d-bece-f268e8e4a44c	2025-03-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Temazepam generic name: TEMAZEPAM
temazepam	TEMAZEPAM	AvPAK	08183adb-af12-fcb2-e063-6394a90afea4	2025-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: temazepam generic name: TEMAZEPAM
Temazepam	TEMAZEPAM	Actavis Pharma, Inc.	a4370eb4-b00d-4247-af8d-980e59fbbec6	2025-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Temazepam generic name: TEMAZEPAM
Temazepam	TEMAZEPAM	Advanced Rx Pharmacy of Tennessee, LLC	d83e14ae-9823-e57b-e053-2a95a90a8524	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Temazepam generic name: TEMAZEPAM
Temazepam	TEMAZEPAM	Advanced Rx Pharmacy of Tennessee, LLC	f885bb1a-0445-c452-e053-6394a90ae8aa	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Temazepam generic name: TEMAZEPAM
Temazepam	TEMAZEPAM	Bryant Ranch Prepack	066e25b2-8a1b-4b08-b585-ce36753bf104	2024-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Temazepam generic name: TEMAZEPAM
temazepam	TEMAZEPAM	Bryant Ranch Prepack	ed068e02-a9c6-41ce-beca-83762720663d	2024-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: temazepam generic name: TEMAZEPAM
Temazepam	TEMAZEPAM	Amneal Pharmaceuticals LLC	be68c6e0-17ad-40fe-9bc1-58abe24b53f6	2024-10-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Temazepam generic name: TEMAZEPAM
temazepam	TEMAZEPAM	Bryant Ranch Prepack	8af67441-167f-4cc8-a498-c4377ba41c6d	2024-08-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: temazepam generic name: TEMAZEPAM
Temazepam	TEMAZEPAM	Bryant Ranch Prepack	44461dcc-5c1e-4852-92d3-854ac0849e3d	2024-08-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Temazepam generic name: TEMAZEPAM
temazepam	TEMAZEPAM	NuCare Pharmaceuticals,Inc.	62fc08cd-8143-1652-e053-2a91aa0ad7ed	2024-08-14	Warnings, Adverse reactions	Name fallback brand name: temazepam generic name: TEMAZEPAM
Temazepam	TEMAZEPAM	Solco Healthcare U.S., LLC	3ce42f0e-821e-4c9a-8f6b-60621628fd4b	2024-07-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Temazepam generic name: TEMAZEPAM
Temazepam	TEMAZEPAM	Golden State Medical Supply, Inc.	1ddc31b7-2b23-fb10-e063-6394a90a55f3	2024-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Temazepam generic name: TEMAZEPAM
Temazepam	TEMAZEPAM CIV	NuCare Pharmaceuticals,Inc.	617d1957-c414-7f34-e053-2a91aa0a3fe0	2024-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Temazepam
TEMAZEPAM	TEMAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	a8deb28b-c5a3-4775-8bec-3f276698d064	2024-06-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TEMAZEPAM generic name: TEMAZEPAM
temazepam	TEMAZEPAM	Bryant Ranch Prepack	a90d9165-da54-48e5-b144-ebeb6ff8d8ab	2024-05-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: temazepam generic name: TEMAZEPAM
temazepam	TEMAZEPAM	Bryant Ranch Prepack	6559dfee-c29b-4707-8b30-8ca14bf23ea0	2024-03-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: temazepam generic name: TEMAZEPAM
temazepam	TEMAZEPAM	Bryant Ranch Prepack	432252c6-648f-4c53-976c-ee271ba435bd	2024-03-07	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.