Application 078654

Type: ANDA
Sponsor: SUN PHARM INDS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLONAZEPAM	CLONAZEPAM	TABLET, ORALLY DISINTEGRATING;ORAL	0.125MG	No	No
002	CLONAZEPAM	CLONAZEPAM	TABLET, ORALLY DISINTEGRATING;ORAL	0.25MG	No	No
003	CLONAZEPAM	CLONAZEPAM	TABLET, ORALLY DISINTEGRATING;ORAL	0.5MG	No	No
004	CLONAZEPAM	CLONAZEPAM	TABLET, ORALLY DISINTEGRATING;ORAL	1MG	No	No
005	CLONAZEPAM	CLONAZEPAM	TABLET, ORALLY DISINTEGRATING;ORAL	2MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A078654-001	CLONAZEPAM	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	2014-08-27
A078654-002	CLONAZEPAM	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	2014-08-27
A078654-003	CLONAZEPAM	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2014-08-27
A078654-004	CLONAZEPAM	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	2014-08-27
A078654-005	CLONAZEPAM	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	2014-08-27

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 6 · 215 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	A078654-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078654-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078654-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078654-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078654-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078654-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078654-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078654-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078654-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078654-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078654-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078654-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078654-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078654-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078654-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078654-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078654-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078654-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078654-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078654-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078654-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078654-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078654-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078654-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078654-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078654-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078654-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078654-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078654-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078654-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078654-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078654-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078654-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078654-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078654-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078654-001	CLONAZEPAM	0.125MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078654-002	CLONAZEPAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078654-003	CLONAZEPAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078654-004	CLONAZEPAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078654-005	CLONAZEPAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-08-27	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 175 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078654-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078654-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078654-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078654-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078654-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078654-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078654-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078654-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078654-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078654-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078654-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078654-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078654-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078654-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078654-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078654-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078654-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078654-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078654-004	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078654-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078654-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078654-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078654-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078654-004	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078654-005	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078654-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078654-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078654-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078654-004	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078654-005	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078654-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078654-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078654-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078654-004	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078654-005	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078654-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078654-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078654-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078654-004	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078654-005	AB	1	`1e350fbaab3a…`

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 5 of 5 · 95 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonazepam	CLONAZEPAM	Chartwell RX, LLC	7b543f77-4388-4227-942f-7933f200b3a5	2023-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	5f3a2f64-57ed-475c-9d8c-b2094bf1d79e	2023-10-26	Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	5ae98718-9da5-4edc-8efb-67b212577548	2023-10-18	Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	cc14bb7b-d0c8-4f41-bcd9-a0c860b45a43	2023-10-18	Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Proficient Rx LP	d65c9a1e-f2f4-46d2-9b28-ba0e5c67e542	2023-10-01	Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Proficient Rx LP	645fb912-479c-46de-b99c-4ea341bfd9ba	2023-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	6be64dc3-3748-477c-8800-2c2175309c73	2023-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	6960e994-e9ea-4a4a-b674-7e6124d8b381	2023-05-25	Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Teva Pharmaceuticals USA, Inc.	8069b1a0-7c06-4252-b44e-e2eef065d9b8	2023-04-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Aurobindo Pharma Limited	b1582eb7-af35-45d5-a52e-0e380d08527d	2023-02-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Limited	43ee20ce-0015-413c-b230-822e390b02f7	2023-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CLONAZEPAM generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Proficient Rx LP	4dcb6785-e16b-4692-89b3-f905979ca5ae	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Proficient Rx LP	56175c25-3fde-43ea-89bf-22dcf3278b6b	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Proficient Rx LP	63286201-4b79-45b8-8f48-7e21dadc1408	2021-02-01	Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	c68420a9-b646-4a4f-99f7-43d652312eb0	2018-02-14	Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM

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 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57664-783	Clonazepam	Clonazepam	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-783	Clonazepam	Clonazepam	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-783	Clonazepam	Clonazepam	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-783	Clonazepam	Clonazepam	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-783	Clonazepam	Clonazepam	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-783	Clonazepam	Clonazepam	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-784	Clonazepam	Clonazepam	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-784	Clonazepam	Clonazepam	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-784	Clonazepam	Clonazepam	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-784	Clonazepam	Clonazepam	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-784	Clonazepam	Clonazepam	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-784	Clonazepam	Clonazepam	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-785	Clonazepam	Clonazepam	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-785	Clonazepam	Clonazepam	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-785	Clonazepam	Clonazepam	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-785	Clonazepam	Clonazepam	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-785	Clonazepam	Clonazepam	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-785	Clonazepam	Clonazepam	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-786	Clonazepam	Clonazepam	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-786	Clonazepam	Clonazepam	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-786	Clonazepam	Clonazepam	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-786	Clonazepam	Clonazepam	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-786	Clonazepam	Clonazepam	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-786	Clonazepam	Clonazepam	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-787	Clonazepam	Clonazepam	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-787	Clonazepam	Clonazepam	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-787	Clonazepam	Clonazepam	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-787	Clonazepam	Clonazepam	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-787	Clonazepam	Clonazepam	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-787	Clonazepam	Clonazepam	Sun Pharmaceutical Industries, Inc.	ANDA	Current