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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 074925

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NDA 074925 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 074925

Tradename:	CLONAZEPAM
Applicant:	Chartwell Rx
Ingredient:	clonazepam
Patents:	0

Pharmacology for NDA: 074925

Medical Subject Heading (MeSH) Categories for 074925

Anticonvulsants
GABA Modulators

Suppliers and Packaging for NDA: 074925

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLONAZEPAM	clonazepam	TABLET;ORAL	074925	ANDA	Chartwell RX, LLC	62135-769	62135-769-90	90 TABLET in 1 BOTTLE (62135-769-90)
CLONAZEPAM	clonazepam	TABLET;ORAL	074925	ANDA	Chartwell RX, LLC	62135-770	62135-770-90	90 TABLET in 1 BOTTLE (62135-770-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Sep 30, 1997	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Sep 30, 1997	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Sep 30, 1997	TE:		RLD:	No

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