Application 077147

Type: ANDA
Sponsor: ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLONAZEPAM	CLONAZEPAM	TABLET;ORAL	0.5MG	No	No
002	CLONAZEPAM	CLONAZEPAM	TABLET;ORAL	1MG	No	No
003	CLONAZEPAM	CLONAZEPAM	TABLET;ORAL	2MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A077147-001	CLONAZEPAM	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02
A077147-002	CLONAZEPAM	CLONAZEPAM	1MG	TABLET / ORAL	AB	2005-05-02
A077147-003	CLONAZEPAM	CLONAZEPAM	2MG	TABLET / ORAL	AB	2005-05-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077147-001	AB
A077147-002	AB
A077147-003	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 · 132 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
2026-10-15 13:18:30	2026-09	A077147-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077147-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2005-05-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077147-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2005-05-02	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077147-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077147-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2005-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077147-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2005-05-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077147-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077147-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2005-05-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077147-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2005-05-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077147-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077147-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2005-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077147-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2005-05-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077147-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077147-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2005-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077147-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2005-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077147-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077147-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2005-05-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077147-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2005-05-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077147-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077147-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2005-05-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077147-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2005-05-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077147-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077147-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2005-05-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077147-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2005-05-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077147-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077147-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2005-05-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077147-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2005-05-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077147-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077147-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2005-05-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077147-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2005-05-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077147-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077147-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2005-05-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077147-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2005-05-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077147-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077147-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2005-05-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077147-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2005-05-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077147-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077147-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	2005-05-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077147-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	2005-05-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077147-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	2005-05-02	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A077147-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077147-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077147-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077147-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077147-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077147-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077147-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077147-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077147-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077147-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077147-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077147-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077147-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077147-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077147-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077147-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077147-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077147-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077147-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077147-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077147-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077147-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077147-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077147-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077147-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077147-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077147-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077147-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077147-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077147-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077147-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077147-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077147-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077147-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077147-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077147-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077147-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077147-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077147-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077147-001	AB	1	`79d66fd596c7…`

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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonazepam	CLONAZEPAM	Proficient Rx LP	d65c9a1e-f2f4-46d2-9b28-ba0e5c67e542	2023-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077147 application number: ANDA077147
Clonazepam	CLONAZEPAM	Proficient Rx LP	4dcb6785-e16b-4692-89b3-f905979ca5ae	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077147 application number: ANDA077147
Clonazepam	CLONAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	c68420a9-b646-4a4f-99f7-43d652312eb0	2018-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077147 application number: ANDA077147 ndc (product): 71610-040

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 3 · 164 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66267-708	Clonazepam	clonazepam	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-748	Clonazepam	clonazepam	Nu Care Pharmaceuticals, Inc.	ANDA	Current
66267-748	Clonazepam	clonazepam	Nu Care Pharmaceuticals, Inc.	ANDA	Current
66267-904	Clonazepam	clonazepam	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-904	Clonazepam	clonazepam	NuCare Pharmaceuticals, Inc.	ANDA	Current
67046-918	Clonazepam	clonazepam	Contract Pharmacy Services-PA	ANDA	Current
67046-921	Clonazepam	clonazepam	Contract Pharmacy Services-PA	ANDA	Current
67046-922	Clonazepam	clonazepam	Contract Pharmacy Services-PA	ANDA	Current
68071-2310	Clonazepam	clonazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2310	Clonazepam	clonazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4021	Clonazepam	clonazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4021	Clonazepam	clonazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4021	Clonazepam	clonazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4135	Clonazepam	clonazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4135	Clonazepam	clonazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5163	Clonazepam	clonazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5163	Clonazepam	clonazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5247	Clonazepam	clonazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5247	Clonazepam	clonazepam	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-6989	Clonazepam	clonazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7181	Clonazepam	clonazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7181	Clonazepam	clonazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7181	Clonazepam	clonazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7181	Clonazepam	clonazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7181	Clonazepam	clonazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7394	Clonazepam	clonazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7394	Clonazepam	clonazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7394	Clonazepam	clonazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7394	Clonazepam	clonazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7394	Clonazepam	clonazepam	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7738	Clonazepam	clonazepam	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7738	Clonazepam	clonazepam	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7738	Clonazepam	clonazepam	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-1297	Clonazepam	clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-1297	Clonazepam	clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-1297	Clonazepam	clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-1297	Clonazepam	clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-1297	Clonazepam	clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-1521	Clonazepam	clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-1521	Clonazepam	clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-1521	Clonazepam	clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-1521	Clonazepam	clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-1521	Clonazepam	clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-1521	Clonazepam	clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-1559	Clonazepam	clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-1559	Clonazepam	clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-1559	Clonazepam	clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-1559	Clonazepam	clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-1559	Clonazepam	clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-1559	Clonazepam	clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-1801	Clonazepam	clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-1801	Clonazepam	clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-1801	Clonazepam	clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-1801	Clonazepam	clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-2232	Clonazepam	clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-2232	Clonazepam	clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-2232	Clonazepam	clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-2232	Clonazepam	clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-2334	Clonazepam	clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-2334	Clonazepam	clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-2334	Clonazepam	clonazepam	REMEDYREPACK INC.	ANDA	Current
70518-2334	Clonazepam	clonazepam	REMEDYREPACK INC.	ANDA	Current
71335-0022	Clonazepam	clonazepam	Bryant Ranch Prepack	ANDA	Current
71335-0022	Clonazepam	clonazepam	Bryant Ranch Prepack	ANDA	Current
71335-0022	Clonazepam	clonazepam	Bryant Ranch Prepack	ANDA	Current
71335-0113	Clonazepam	clonazepam	Bryant Ranch Prepack	ANDA	Current
71335-0113	Clonazepam	clonazepam	Bryant Ranch Prepack	ANDA	Current
71335-0113	Clonazepam	clonazepam	Bryant Ranch Prepack	ANDA	Current
71335-0333	Clonazepam	clonazepam	Bryant Ranch Prepack	ANDA	Current
71335-0333	Clonazepam	clonazepam	Bryant Ranch Prepack	ANDA	Current
71335-0333	Clonazepam	clonazepam	Bryant Ranch Prepack	ANDA	Current
71610-039	Clonazepam	clonazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-040	Clonazepam	clonazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-390	Clonazepam	clonazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
80425-0125	Klonopin	Clonazepam 0.5mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0125	Clonazepam	Clonazepam	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0125	Clonazepam	Clonazepam	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0125	Clonazepam	Clonazepam	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0125	Clonazepam	Clonazepam	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0125	Clonazepam	Clonazepam	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current