Last Updated: May 3, 2026

Details for New Drug Application (NDA): 075423

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NDA 075423 describes CLONAZEPAM, which is a drug marketed by Alembic, Barr, Ph Health, Sun Pharm Inds Inc, Accord Hlthcare, Actavis Elizabeth, Aurobindo Pharma Usa, Chartwell Rx, Pharmobedient, Prinston Inc, Rubicon Research, Sandoz, Teva, and Watson Labs, and is included in sixteen NDAs. It is available from twenty-nine suppliers. Additional details are available on the CLONAZEPAM profile page.

The generic ingredient in CLONAZEPAM is clonazepam. There are ten drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the clonazepam profile page.

Summary for 075423

Tradename:	CLONAZEPAM
Applicant:	Sun Pharm Inds Inc
Ingredient:	clonazepam
Patents:	0

Medical Subject Heading (MeSH) Categories for 075423

Anticonvulsants
GABA Modulators

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Apr 27, 2001	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Apr 27, 2001	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Apr 27, 2001	TE:		RLD:	No

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