Application 071457

Type: ANDA
Sponsor: NOVEL LABS INC

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A071457-001	TEMAZEPAM	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-04-21
A071457-002	TEMAZEPAM	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2012-06-22
A071457-003	TEMAZEPAM	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2012-06-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A071457-001	AB
A071457-002	AB
A071457-003	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 4 · 129 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	A071457-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-04-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071457-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2012-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071457-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2012-06-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071457-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071457-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2012-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071457-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2012-06-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071457-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071457-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2012-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071457-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2012-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071457-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071457-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2012-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071457-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2012-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071457-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071457-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2012-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071457-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2012-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071457-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071457-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2012-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071457-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2012-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071457-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071457-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2012-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071457-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2012-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071457-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071457-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2012-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071457-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2012-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071457-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071457-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2012-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071457-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2012-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071457-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-04-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071457-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2012-06-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071457-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2012-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071457-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-04-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071457-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2012-06-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071457-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2012-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071457-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-04-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071457-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2012-06-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071457-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2012-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071457-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-04-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071457-002	TEMAZEPAM	7.5MG	CAPSULE / ORAL	AB	2012-06-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071457-003	TEMAZEPAM	22.5MG	CAPSULE / ORAL	AB	2012-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071457-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-04-21	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A071457-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071457-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071457-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071457-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071457-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071457-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071457-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071457-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071457-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071457-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071457-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071457-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071457-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071457-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071457-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071457-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071457-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071457-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071457-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071457-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071457-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071457-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071457-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071457-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071457-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071457-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071457-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071457-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071457-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071457-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071457-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071457-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071457-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071457-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071457-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071457-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071457-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071457-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071457-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071457-001	AB	1	`301d65b070ca…`

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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
temazepam	TEMAZEPAM	Bryant Ranch Prepack	5d83e474-0932-49ae-ad92-ca278cd5f1d5	2026-09-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	Bryant Ranch Prepack	1c08d30d-7c27-a09a-5240-7050771d5cc7	2026-09-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
Temazepam	TEMAZEPAM	Major Pharmaceuticals	2c4f564d-d349-4f9b-b3f4-f3f0d9706a4d	2026-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	PD-Rx Pharmaceuticals, Inc.	62379cd5-a314-43eb-a1ee-33997623bfa3	2026-08-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	Ascend Laboratories, LLC	8f54731f-c5b7-492c-acb0-444c5fbb7029	2026-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457 ndc (product): 67877-149 ndc (product): 67877-148
temazepam	TEMAZEPAM	Preferred Pharmaceuticals Inc.	7e3fd8fe-fb8a-4577-b540-0e3fefe63627	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457 ndc (product): 68788-8081
temazepam	TEMAZEPAM	Bryant Ranch Prepack	4fe8192a-0f65-4958-8b6d-e87b9fae9eb5	2025-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	Bryant Ranch Prepack	bbb6e233-dc6b-43a7-8203-d91421d89921	2025-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	A-S Medication Solutions	19b2711e-587a-47d2-ab62-d564e7b87195	2025-10-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	Bryant Ranch Prepack	dadc2f66-7fa5-4be4-a9d0-d96e5836f550	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	Asclemed USA, Inc.	254a0273-c0f3-4d2d-b18e-4ab51ba4bc50	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	AvPAK	08183adb-af12-fcb2-e063-6394a90afea4	2025-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	Bryant Ranch Prepack	ed068e02-a9c6-41ce-beca-83762720663d	2024-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	Bryant Ranch Prepack	8af67441-167f-4cc8-a498-c4377ba41c6d	2024-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	NuCare Pharmaceuticals,Inc.	62fc08cd-8143-1652-e053-2a91aa0ad7ed	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	Bryant Ranch Prepack	6559dfee-c29b-4707-8b30-8ca14bf23ea0	2024-03-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	Bryant Ranch Prepack	147a51d7-2f8d-43e8-b0ed-a79a2cdfc0a9	2024-03-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	b2422ca0-2f06-419f-aa0e-88c556b62399	2024-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	Bryant Ranch Prepack	1e37d59b-b8be-46ef-8706-fffd563a8c15	2024-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457
temazepam	TEMAZEPAM	Bryant Ranch Prepack	0e752dda-f00f-4123-b59f-aa911b897a5a	2023-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071457 application number: ANDA071457

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 96 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67877-148	temazepam	temazepam	Ascend Laboratories, LLC	ANDA	Current
67877-148	temazepam	temazepam	Ascend Laboratories, LLC	ANDA	Current
67877-149	temazepam	temazepam	Ascend Laboratories, LLC	ANDA	Current
67877-149	temazepam	temazepam	Ascend Laboratories, LLC	ANDA	Current
67877-149	temazepam	temazepam	Ascend Laboratories, LLC	ANDA	Current
68788-8081	temazepam	temazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8081	temazepam	temazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9864	temazepam	temazepam	Preferred Pharmaceuticals	ANDA	Current
70518-2008	temazepam	temazepam	REMEDYREPACK INC.	ANDA	Current
70518-2008	temazepam	temazepam	REMEDYREPACK INC.	ANDA	Current
70518-2008	temazepam	temazepam	REMEDYREPACK INC.	ANDA	Current
71205-915	temazepam	temazepam	Proficient Rx LP	ANDA	Current
71205-915	temazepam	temazepam	Proficient Rx LP	ANDA	Current
71335-1151	temazepam	temazepam	Bryant Ranch Prepack	ANDA	Current
71610-101	temazepam	temazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-262	temazepam	temazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current