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Last Updated: April 19, 2024

Details for New Drug Application (NDA): 202873

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NDA 202873 describes CLOZAPINE, which is a drug marketed by Barr Labs Inc, Mylan, Teva Pharms Usa, 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 thirteen NDAs. It is available from thirteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the clozapine profile page.

Summary for 202873

Tradename:	CLOZAPINE
Applicant:	Accord Hlthcare
Ingredient:	clozapine
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 202873

Medical Subject Heading (MeSH) Categories for 202873

Antipsychotic Agents
GABA Antagonists
Serotonin Antagonists

Suppliers and Packaging for NDA: 202873

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOZAPINE	clozapine	TABLET;ORAL	202873	ANDA	Accord Healthcare Inc.	16729-141	16729-141-01	100 TABLET in 1 BOTTLE (16729-141-01)
CLOZAPINE	clozapine	TABLET;ORAL	202873	ANDA	Accord Healthcare Inc.	16729-141	16729-141-16	500 TABLET in 1 BOTTLE (16729-141-16)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Nov 25, 2015	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Nov 25, 2015	TE:	AB	RLD:	No

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