Application 211542

Type: ANDA
Sponsor: ALEMBIC PHARMS 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 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
A211542-001	TEMAZEPAM	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2018-11-23
A211542-002	TEMAZEPAM	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2018-11-23
A211542-003	TEMAZEPAM	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2018-11-23
A211542-004	TEMAZEPAM	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2018-11-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211542-001	AB
A211542-002	AB
A211542-003	AB
A211542-004	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	A211542-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2018-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211542-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2018-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211542-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2018-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211542-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2018-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211542-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2018-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211542-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2018-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211542-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2018-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211542-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2018-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211542-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2018-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211542-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2018-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211542-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2018-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211542-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2018-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211542-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2018-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211542-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2018-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211542-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2018-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211542-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2018-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211542-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2018-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211542-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2018-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211542-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2018-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211542-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2018-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211542-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2018-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211542-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2018-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211542-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2018-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211542-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2018-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211542-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2018-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211542-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2018-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211542-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2018-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211542-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2018-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211542-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2018-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211542-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2018-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211542-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2018-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211542-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2018-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211542-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2018-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211542-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2018-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211542-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2018-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211542-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2018-11-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211542-001	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2018-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211542-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	2018-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211542-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2018-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211542-004	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	2018-11-23	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A211542-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211542-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211542-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211542-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211542-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211542-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211542-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211542-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211542-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211542-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211542-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211542-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211542-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211542-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211542-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211542-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211542-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211542-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211542-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211542-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211542-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211542-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211542-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211542-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211542-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211542-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211542-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211542-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211542-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211542-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211542-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211542-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211542-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211542-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211542-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211542-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211542-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211542-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211542-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211542-004	AB	1	`d06236e962d9…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Temazepam	TEMAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	4a2ab77d-8b80-7eb1-e063-6394a90a1469	2026-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211542 application number: ANDA211542
Temazepam	TEMAZEPAM	Preferred Pharmaceuticals Inc.	cbe5bd6a-f36a-4557-82d8-ef4e49d310e9	2025-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211542 application number: ANDA211542
Temazepam	TEMAZEPAM	Bryant Ranch Prepack	44461dcc-5c1e-4852-92d3-854ac0849e3d	2024-08-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211542 application number: ANDA211542
Temazepam	TEMAZEPAM	Golden State Medical Supply, Inc.	1ddc31b7-2b23-fb10-e063-6394a90a55f3	2024-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211542 application number: ANDA211542
Temazepam	TEMAZEPAM	Bryant Ranch Prepack	74a3db09-94d0-45e1-8c68-da7ca49d3d59	2023-11-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211542 application number: ANDA211542 ndc (product): 71335-2043
Temazepam	TEMAZEPAM	Alembic Pharmaceuticals Inc.	93b1be7f-ec41-46bb-a258-56cb459e2c92	2023-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211542 application number: ANDA211542 ndc (product): 62332-380 ndc (product): 62332-381 ndc (product): 62332-379 ndc (product): 62332-382
Temazepam	TEMAZEPAM	Alembic Pharmaceuticals Limited	db839409-8e95-41d3-804e-dcd5d11f4934	2023-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211542 application number: ANDA211542 ndc (product): 46708-381 ndc (product): 46708-379 ndc (product): 46708-380 ndc (product): 46708-382

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-379	Temazepam	Temazepam	Alembic Pharmaceuticals Limited	ANDA	Current
46708-380	Temazepam	Temazepam	Alembic Pharmaceuticals Limited	ANDA	Current
46708-381	Temazepam	Temazepam	Alembic Pharmaceuticals Limited	ANDA	Current
46708-382	Temazepam	Temazepam	Alembic Pharmaceuticals Limited	ANDA	Current
62332-379	Temazepam	Temazepam	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-379	Temazepam	Temazepam	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-379	Temazepam	Temazepam	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-379	Temazepam	Temazepam	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-380	Temazepam	Temazepam	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-380	Temazepam	Temazepam	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-380	Temazepam	Temazepam	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-380	Temazepam	Temazepam	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-381	Temazepam	Temazepam	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-381	Temazepam	Temazepam	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-381	Temazepam	Temazepam	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-381	Temazepam	Temazepam	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-382	Temazepam	Temazepam	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-382	Temazepam	Temazepam	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-382	Temazepam	Temazepam	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-382	Temazepam	Temazepam	Alembic Pharmaceuticals Inc.	ANDA	Current
70518-3093	Temazepam	Temazepam	REMEDYREPACK INC.	ANDA	Current
70518-3605	Temazepam	Temazepam	REMEDYREPACK INC.	ANDA	Current
71335-2043	Temazepam	Temazepam	Bryant Ranch Prepack	ANDA	Current