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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 075713

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NDA 075713 describes CLOZAPINE, which is a drug marketed by Aurobindo Pharma, Barr Labs Inc, Mylan, Accord Hlthcare, Dr Reddys Labs Sa, Ivax Sub Teva Pharms, Par Pharm, Sandoz, Sun Pharm Inds Inc, and Zydus Pharms, and is included in thirteen NDAs. It is available from nine suppliers. Additional details are available on the CLOZAPINE profile page.

The generic ingredient in CLOZAPINE is clozapine. There are thirteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the clozapine profile page.

Summary for 075713

Tradename:	CLOZAPINE
Applicant:	Sun Pharm Inds Inc
Ingredient:	clozapine
Patents:	0

Pharmacology for NDA: 075713

Medical Subject Heading (MeSH) Categories for 075713

Antipsychotic Agents
GABA Antagonists
Serotonin Antagonists

Suppliers and Packaging for NDA: 075713

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOZAPINE	clozapine	TABLET;ORAL	075713	ANDA	Bryant Ranch Prepack	63629-2361	63629-2361-1	100 TABLET in 1 BOTTLE (63629-2361-1)
CLOZAPINE	clozapine	TABLET;ORAL	075713	ANDA	Bryant Ranch Prepack	63629-2362	63629-2362-1	100 TABLET in 1 BOTTLE (63629-2362-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Nov 15, 2002	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Nov 15, 2002	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Aug 19, 2005	TE:		RLD:	No

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