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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 078654

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NDA 078654 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 thirty 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-one suppliers are listed for this compound. Additional details are available on the clonazepam profile page.

Summary for 078654

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

Medical Subject Heading (MeSH) Categories for 078654

Anticonvulsants
GABA Modulators

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	0.125MG
Approval Date:	Aug 27, 2014	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	0.25MG
Approval Date:	Aug 27, 2014	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	0.5MG
Approval Date:	Aug 27, 2014	TE:		RLD:	No

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