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 2 of 5 · 94 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonazepam	CLONAZEPAM	Preferred Pharmaceuticals Inc.	87f362a7-cf66-4166-af51-ac2da473cf6b	2026-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Preferred Pharmaceuticals Inc.	939dee35-3987-4ce2-9985-3751ceffa20e	2026-03-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	REMEDYREPACK INC.	00f323c0-e007-40df-ae7f-e6b3c7ba0aa8	2026-03-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Proficient Rx LP	44f39aa8-a7bc-4e42-977c-31583e6388ae	2026-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	AvPAK	f2662808-01c4-330c-e053-2a95a90aa335	2026-02-24	Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	REMEDYREPACK INC.	a4185456-68f9-47d4-9952-fcdef86989db	2026-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	REMEDYREPACK INC.	095a80b0-09f9-4bd1-b377-5212d7c966ba	2026-02-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Northstar Rx LLC	017534e6-49ff-45f3-b88f-2f34cf0cf8fd	2026-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Klonopin	CLONAZEPAM	H2-Pharma, LLC	cfa0d79a-843c-4b88-95a1-e9511d649ca1	2025-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	PD-Rx Pharmaceuticals, Inc.	9ee4e019-6a99-4aac-84b0-9aae597815a7	2025-10-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	PD-Rx Pharmaceuticals, Inc.	c707caa1-d6fd-4790-9a64-f749bf93ef18	2025-10-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	PD-Rx Pharmaceuticals, Inc.	1ce88d2c-70f7-427b-8787-4afd9ce6f71c	2025-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Par Health USA, LLC	1aef0069-80ea-483d-ac70-c8d485462c5b	2025-10-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	PD-Rx Pharmaceuticals, Inc.	08d0a109-3307-47b5-8ff2-c0ad83e66f08	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	PD-Rx Pharmaceuticals, Inc.	9a74ea97-1c00-4d96-a06f-81c183943dc6	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	PD-Rx Pharmaceuticals, Inc.	ca79f244-7e6e-4612-af26-e6e5cefbd3a2	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Solco Healthcare LLC	4acbb7a9-4db5-4497-b8db-9f358b3f6fb4	2025-08-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
CLONAZEPAM	CLONAZEPAM	Alembic Pharmaceuticals Inc.	ecb28fcb-f0d1-4558-b460-ecabd0f6009e	2025-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CLONAZEPAM generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	dec8b5b2-2490-4880-a8d1-707b57954297	2025-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clonazepam generic name: CLONAZEPAM
Clonazepam	CLONAZEPAM	A-S Medication Solutions	28675dd6-b952-4e71-b0a3-b701ad6b6344	2025-06-09	Boxed warning, 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