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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 075162

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NDA 075162 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 eleven 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. Thirteen suppliers are listed for this compound. Additional details are available on the clozapine profile page.

Summary for 075162

Tradename:	CLOZAPINE
Applicant:	Par Pharm
Ingredient:	clozapine
Patents:	0

Medical Subject Heading (MeSH) Categories for 075162

Antipsychotic Agents
GABA Antagonists
Serotonin Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Apr 26, 2005	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Apr 26, 2005	TE:		RLD:	No

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