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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 074949

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NDA 074949 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 074949

Tradename:	CLOZAPINE
Applicant:	Ivax Sub Teva Pharms
Ingredient:	clozapine
Patents:	0

Medical Subject Heading (MeSH) Categories for 074949

Antipsychotic Agents
GABA Antagonists
Serotonin Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Nov 26, 1997	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Nov 26, 1997	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	12.5MG
Approval Date:	Jul 31, 2003	TE:		RLD:	No

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