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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 075468

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NDA 075468 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 075468

Tradename:	CLONAZEPAM
Applicant:	Rubicon Research
Ingredient:	clonazepam
Patents:	0

Pharmacology for NDA: 075468

Medical Subject Heading (MeSH) Categories for 075468

Anticonvulsants
GABA Modulators

Suppliers and Packaging for NDA: 075468

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLONAZEPAM	clonazepam	TABLET;ORAL	075468	ANDA	Clinical Solutions Wholesale, LLC	58118-0152	58118-0152-8	30 TABLET in 1 BLISTER PACK (58118-0152-8)
CLONAZEPAM	clonazepam	TABLET;ORAL	075468	ANDA	Clinical Solutions Wholesale, LLC	58118-0153	58118-0153-8	30 TABLET in 1 BLISTER PACK (58118-0153-8)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Oct 6, 2000	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Oct 6, 2000	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Oct 6, 2000	TE:	AB	RLD:	No

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