Application 075423

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;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 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	Approval date
A075423-001	CLONAZEPAM	CLONAZEPAM	0.5MG	TABLET / ORAL	2001-04-27
A075423-002	CLONAZEPAM	CLONAZEPAM	1MG	TABLET / ORAL	2001-04-27
A075423-003	CLONAZEPAM	CLONAZEPAM	2MG	TABLET / ORAL	2001-04-27

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075423-001	CLONAZEPAM	0.5MG	TABLET / ORAL	2001-04-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075423-002	CLONAZEPAM	1MG	TABLET / ORAL	2001-04-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075423-003	CLONAZEPAM	2MG	TABLET / ORAL	2001-04-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075423-001	CLONAZEPAM	0.5MG	TABLET / ORAL	2001-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075423-002	CLONAZEPAM	1MG	TABLET / ORAL	2001-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075423-003	CLONAZEPAM	2MG	TABLET / ORAL	2001-04-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075423-001	CLONAZEPAM	0.5MG	TABLET / ORAL	2001-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075423-002	CLONAZEPAM	1MG	TABLET / ORAL	2001-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075423-003	CLONAZEPAM	2MG	TABLET / ORAL	2001-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075423-001	CLONAZEPAM	0.5MG	TABLET / ORAL	2001-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075423-002	CLONAZEPAM	1MG	TABLET / ORAL	2001-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075423-003	CLONAZEPAM	2MG	TABLET / ORAL	2001-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075423-001	CLONAZEPAM	0.5MG	TABLET / ORAL	2001-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075423-002	CLONAZEPAM	1MG	TABLET / ORAL	2001-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075423-003	CLONAZEPAM	2MG	TABLET / ORAL	2001-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075423-001	CLONAZEPAM	0.5MG	TABLET / ORAL	2001-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075423-002	CLONAZEPAM	1MG	TABLET / ORAL	2001-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075423-003	CLONAZEPAM	2MG	TABLET / ORAL	2001-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075423-001	CLONAZEPAM	0.5MG	TABLET / ORAL	2001-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075423-002	CLONAZEPAM	1MG	TABLET / ORAL	2001-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075423-003	CLONAZEPAM	2MG	TABLET / ORAL	2001-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075423-001	CLONAZEPAM	0.5MG	TABLET / ORAL	2001-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075423-002	CLONAZEPAM	1MG	TABLET / ORAL	2001-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075423-003	CLONAZEPAM	2MG	TABLET / ORAL	2001-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075423-001	CLONAZEPAM	0.5MG	TABLET / ORAL	2001-04-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075423-002	CLONAZEPAM	1MG	TABLET / ORAL	2001-04-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075423-003	CLONAZEPAM	2MG	TABLET / ORAL	2001-04-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075423-001	CLONAZEPAM	0.5MG	TABLET / ORAL	2001-04-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075423-002	CLONAZEPAM	1MG	TABLET / ORAL	2001-04-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075423-003	CLONAZEPAM	2MG	TABLET / ORAL	2001-04-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075423-001	CLONAZEPAM	0.5MG	TABLET / ORAL	2001-04-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075423-002	CLONAZEPAM	1MG	TABLET / ORAL	2001-04-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075423-003	CLONAZEPAM	2MG	TABLET / ORAL	2001-04-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075423-001	CLONAZEPAM	0.5MG	TABLET / ORAL	2001-04-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075423-002	CLONAZEPAM	1MG	TABLET / ORAL	2001-04-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075423-003	CLONAZEPAM	2MG	TABLET / ORAL	2001-04-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075423-001	CLONAZEPAM	0.5MG	TABLET / ORAL	2001-04-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075423-002	CLONAZEPAM	1MG	TABLET / ORAL	2001-04-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075423-003	CLONAZEPAM	2MG	TABLET / ORAL	2001-04-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075423-001	CLONAZEPAM	0.5MG	TABLET / ORAL	2001-04-27	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A075423-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075423-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075423-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075423-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075423-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075423-003	AB	1	`ea99ee380514…`

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 3 of 5 · 94 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonazepam	CLONAZEPAM	St Marys Medical Park Pharmacy	31a7ed52-48a6-1c87-e054-00144ff88e88	2025-05-22	Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	American Health Packaging	c13297e2-ae3e-4198-b7c8-55fd672436aa	2025-03-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Coupler LLC	2e970dc2-cd78-bcdf-e063-6294a90ad3e0	2025-02-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Coupler LLC	2cdb55a7-54e4-17b6-e063-6294a90ac827	2025-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Direct_Rx	fc75869c-cd6b-44a3-e053-6294a90a699e	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
CLONAZEPAM	CLONAZEPAM	DIRECT RX	a821f647-be5f-274c-e053-2a95a90a23ce	2025-01-17	Warnings, Adverse reactions	Name fallback brand name: CLONAZEPAM generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Advanced Rx of Tennessee, LLC	04db8e8c-38f9-0c4a-e063-6394a90a93f0	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Advanced Rx Pharmacy of Tennessee, LLC	b9309a1a-a794-2f62-e053-2a95a90a7c34	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Advanced Rx Pharmacy of Tennessee, LLC	be383e56-d71f-7699-e053-2995a90a50c1	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	263f99eb-9744-5601-e063-6394a90a47b1	2024-11-14	Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	8891c5aa-f42a-4206-92b9-f0ed0631dfcb	2024-10-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	214e760b-c909-bd93-e063-6294a90ae74a	2024-10-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	NuCare Pharmaceuticals,Inc.	555061d4-276a-4716-e054-00144ff88e88	2024-10-16	Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	66bf60fa-61ac-47a7-a081-36077af9007e	2024-10-14	Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	7b0d716c-8f51-47a7-8bf2-07c6f9732a05	2024-09-29	Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	20b3125e-4489-3c53-e063-6294a90a6539	2024-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	b12661a6-2141-42a9-bcb0-c0aef81395ce	2024-08-23	Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	b83009c2-26ed-45fa-819e-164cdac264e6	2024-08-23	Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	96518266-8f75-4301-b8fd-d2995a7f486d	2024-08-06	Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	f06dc5fc-94e0-496e-bdf0-11f2b6ffc786	2024-08-06	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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57664-273	CLONAZEPAM	CLONAZEPAM	Caraco Pharmaceutical Laboratories, Ltd.	ANDA	Current
57664-274	CLONAZEPAM	CLONAZEPAM	Caraco Pharmaceutical Laboratories, Ltd.	ANDA	Current
57664-275	CLONAZEPAM	CLONAZEPAM	Caraco Pharmaceutical Laboratories, Ltd.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30879	ORIG	2001-04-27