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Last Updated: December 11, 2024

Details for New Drug Application (NDA): 203807

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NDA 203807 describes CLOZAPINE, which is a drug marketed by Barr Labs Inc, Mylan, Accord Hlthcare, Aurobindo Pharma, Dr Reddys Labs Sa, Ivax Sub Teva Pharms, Par Pharm, Sandoz, Sun Pharm Inds Inc, and Zydus Pharms, and is included in twelve NDAs. It is available from ten 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. Twelve suppliers are listed for this compound. Additional details are available on the clozapine profile page.

Summary for 203807

Tradename:	CLOZAPINE
Applicant:	Dr Reddys Labs Sa
Ingredient:	clozapine
Patents:	0

Medical Subject Heading (MeSH) Categories for 203807

Antipsychotic Agents
GABA Antagonists
Serotonin Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Sep 17, 2015	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Sep 17, 2015	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Aug 22, 2017	TE:		RLD:	No

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