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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 075150

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NDA 075150 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 075150

Tradename:	CLONAZEPAM
Applicant:	Aurobindo Pharma Usa
Ingredient:	clonazepam
Patents:	0

Pharmacology for NDA: 075150

Medical Subject Heading (MeSH) Categories for 075150

Anticonvulsants
GABA Modulators

Suppliers and Packaging for NDA: 075150

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLONAZEPAM	clonazepam	TABLET;ORAL	075150	ANDA	Aurobindo Pharma Limited	59651-722	59651-722-01	100 TABLET in 1 BOTTLE (59651-722-01)
CLONAZEPAM	clonazepam	TABLET;ORAL	075150	ANDA	Aurobindo Pharma Limited	59651-722	59651-722-99	1000 TABLET in 1 BOTTLE (59651-722-99)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Oct 5, 1998	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Oct 5, 1998	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Oct 5, 1998	TE:	AB	RLD:	No

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