Application 071427

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TEMAZEPAM	TEMAZEPAM	CAPSULE;ORAL	15MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A071427-001	TEMAZEPAM	TEMAZEPAM	15MG	CAPSULE / ORAL	AB		1988-01-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071427-001	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 2 · 41 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	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071427-001	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1988-01-12	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A071427-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071427-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071427-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071427-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071427-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071427-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071427-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071427-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071427-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071427-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071427-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071427-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071427-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071427-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071427-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071427-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071427-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071427-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071427-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071427-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071427-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071427-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071427-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071427-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071427-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071427-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071427-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071427-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071427-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071427-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071427-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071427-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071427-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071427-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071427-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071427-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071427-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071427-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071427-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071427-001	AB	1	`cb3db0bc1861…`

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 · 57 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
temazepam	TEMAZEPAM	REMEDYREPACK INC.	65857a9b-a225-4887-b0dc-58ab6d60f9d0	2026-06-30	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.	62379cd5-a314-43eb-a1ee-33997623bfa3	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
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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-7808	Temazepam	Temazepam	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0781-2201	Temazepam	Temazepam	Sandoz Inc	ANDA	Current
0781-2201	Temazepam	Temazepam	Sandoz Inc	ANDA	Current
63739-231	Temazepam	Temazepam	McKesson Packaging Services a business unit of McKesson Corporation	ANDA	Current
63739-231	Temazepam	Temazepam	McKesson Corporation dba SKY Packaging	ANDA	Current
67544-038	Temazepam	Temazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current