Last Updated: November 8, 2026

Details for New Drug Application (NDA): 076911

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NDA 076911 describes CLORAZEPATE DIPOTASSIUM, which is a drug marketed by Able, Am Therap, Dava Pharms Inc, Gd Searle Llc, Natco Pharma Usa, Purepac Pharm, Quantum Pharmics, Rising, Usl Pharma, Warner Chilcott, Watson Labs, Aurobindo Pharma, Aurolife Pharma Llc, Lederle, Macleods Pharms, Novitium Pharma, Sun Pharm Inds Ltd, and Taro, and is included in fifty-eight NDAs. It is available from eight suppliers. Additional details are available on the CLORAZEPATE DIPOTASSIUM profile page.

The generic ingredient in CLORAZEPATE DIPOTASSIUM is clorazepate dipotassium. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the clorazepate dipotassium profile page.

Summary for 076911

Tradename:	CLORAZEPATE DIPOTASSIUM
Applicant:	Sun Pharm Inds Ltd
Ingredient:	clorazepate dipotassium
Patents:	0

Medical Subject Heading (MeSH) Categories for 076911

Anti-Anxiety Agents
Anticonvulsants
GABA Modulators

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	3.75MG
Approval Date:	Sep 29, 2004	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	7.5MG
Approval Date:	Sep 29, 2004	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	15MG
Approval Date:	Sep 29, 2004	TE:		RLD:	No

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