Application 071620

Type: ANDA
Sponsor: ACTAVIS ELIZABETH

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	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A071620-001	TEMAZEPAM	TEMAZEPAM	30MG	CAPSULE / ORAL	AB		1987-08-07
A071620-002	TEMAZEPAM	TEMAZEPAM	15MG	CAPSULE / ORAL	AB		1987-08-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A071620-001	AB
A071620-002	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 · 82 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	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071620-001	TEMAZEPAM	30MG	CAPSULE / ORAL	AB	1987-08-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A071620-002	TEMAZEPAM	15MG	CAPSULE / ORAL	AB	1987-08-07	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A071620-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071620-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071620-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071620-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071620-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071620-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071620-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071620-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071620-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071620-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071620-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071620-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071620-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071620-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071620-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071620-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071620-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071620-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071620-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071620-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071620-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071620-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071620-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071620-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071620-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071620-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071620-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A071620-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071620-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071620-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071620-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071620-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071620-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071620-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071620-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071620-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071620-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A071620-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071620-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A071620-002	AB	1	`782e0a99824c…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Temazepam	TEMAZEPAM	REMEDYREPACK INC.	85919240-0bac-4ed9-97aa-f1aa29be7ffa	2026-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071620 application number: ANDA071620 ndc (product): 70518-2487
Temazepam	TEMAZEPAM	Bryant Ranch Prepack	38afa73c-7c87-440d-bece-f268e8e4a44c	2025-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071620 application number: ANDA071620 ndc (product): 71335-0315
Temazepam	TEMAZEPAM	Actavis Pharma, Inc.	a4370eb4-b00d-4247-af8d-980e59fbbec6	2025-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071620 application number: ANDA071620 ndc (product): 0228-2077 ndc (product): 0228-2076
Temazepam	TEMAZEPAM CIV	NuCare Pharmaceuticals,Inc.	617d1957-c414-7f34-e053-2a91aa0a3fe0	2024-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071620 application number: ANDA071620 ndc (product): 68071-4083

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 57 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0228-2076	Temazepam	Temazepam	Actavis Pharma, Inc.	ANDA	Current
0228-2076	Temazepam	Temazepam	Actavis Pharma, Inc.	ANDA	Current
0228-2076	Temazepam	Temazepam	Actavis Pharma, Inc.	ANDA	Current
0228-2076	Temazepam	Temazepam	Actavis Pharma, Inc.	ANDA	Current
0228-2076	Temazepam	Temazepam	Actavis Pharma, Inc.	ANDA	Current
0228-2077	Temazepam	Temazepam	Actavis Pharma, Inc.	ANDA	Current
0228-2077	Temazepam	Temazepam	Actavis Pharma, Inc.	ANDA	Current
0228-2077	Temazepam	Temazepam	Actavis Pharma, Inc.	ANDA	Current
0228-2077	Temazepam	Temazepam	Actavis Pharma, Inc.	ANDA	Current
0228-2077	Temazepam	Temazepam	Actavis Pharma, Inc.	ANDA	Current
50090-2356	Temazepam	Temazepam	A-S Medication Solutions	ANDA	Current
50090-2356	Temazepam	Temazepam	A-S Medication Solutions	ANDA	Current
50090-2391	Temazepam	Temazepam	A-S Medication Solutions	ANDA	Current
50436-4628	Temazepam	Temazepam	Unit Dose Services	ANDA	Current
50436-4628	Temazepam	Temazepam	Unit Dose Services	ANDA	Current
50436-4629	Temazepam	Temazepam	Unit Dose Services	ANDA	Current
60429-506	Temazepam	Temazepam	GSMS, Incorporated	ANDA	Current
60429-506	Temazepam	Temazepam	Golden State Medical Supply, Inc.	ANDA	Current
60429-506	Temazepam	Temazepam	Golden State Medical Supply	ANDA	Current
60429-506	Temazepam	Temazepam	Golden State Medical Supply, Inc.	ANDA	Current
60429-507	Temazepam	Temazepam	GSMS, Incorporated	ANDA	Current
60429-507	Temazepam	Temazepam	Golden State Medical Supply, Inc.	ANDA	Current
60429-507	Temazepam	Temazepam	Golden State Medical Supply	ANDA	Current
60429-507	Temazepam	Temazepam	Golden State Medical Supply, Inc.	ANDA	Current
61919-438	TEMAZEPAM	TEMAZEPAM	Direct Rx	ANDA	Current
61919-438	TEMAZEPAM	TEMAZEPAM	Direct Rx	ANDA	Current
61919-438	TEMAZEPAM	TEMAZEPAM	Direct Rx	ANDA	Current
63629-7713	Temazepam	Temazepam	Bryant Ranch Prepack	ANDA	Current
63629-7715	Temazepam	Temazepam	Bryant Ranch Prepack	ANDA	Current
63629-7715	Temazepam	Temazepam	Bryant Ranch Prepack	ANDA	Current
68071-4083	Temazepam	Temazepam CIV	NuCare Pharmaceuticals,In	ANDA	Current
68071-4083	Temazepam	Temazepam CIV	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4083	Temazepam	Temazepam CIV	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4100	Temazepam	Temazepam CIV	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4100	Temazepam	Temazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-6986	Temazepam	Temazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6986	Temazepam	Temazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6986	Temazepam	Temazepam	Preferred Pharmaceuticals	ANDA	Current
68788-6986	Temazepam	Temazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6986	Temazepam	Temazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7163	Temazepam	Temazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7163	Temazepam	Temazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7163	Temazepam	Temazepam	Preferred Pharmaceuticals	ANDA	Current
68788-7163	Temazepam	Temazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7163	Temazepam	Temazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-2487	Temazepam	Temazepam	REMEDYREPACK INC.	ANDA	Current
70518-2487	Temazepam	Temazepam	REMEDYREPACK INC.	ANDA	Current
70518-2487	Temazepam	Temazepam	REMEDYREPACK INC.	ANDA	Current
70518-2487	Temazepam	Temazepam	REMEDYREPACK INC.	ANDA	Current
70518-2487	Temazepam	Temazepam	REMEDYREPACK INC.	ANDA	Current
70518-2926	Temazepam	Temazepam	REMEDYREPACK INC.	ANDA	Current
71335-0315	Temazepam	Temazepam	Bryant Ranch Prepack	ANDA	Current
71335-0315	Temazepam	Temazepam	Bryant Ranch Prepack	ANDA	Current
71335-0315	Temazepam	Temazepam	Bryant Ranch Prepack	ANDA	Current
71335-0527	Temazepam	Temazepam	Bryant Ranch Prepack	ANDA	Current
71335-0527	Temazepam	Temazepam	Bryant Ranch Prepack	ANDA	Current
71335-0527	Temazepam	Temazepam	Bryant Ranch Prepack	ANDA	Current