Last Updated: November 8, 2026

Details for New Drug Application (NDA): 206433

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NDA 206433 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 is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the clozapine profile page.

Summary for 206433

Tradename:	CLOZAPINE
Applicant:	Aurobindo Pharma
Ingredient:	clozapine
Patents:	0

Pharmacology for NDA: 206433

Medical Subject Heading (MeSH) Categories for 206433

Antipsychotic Agents
GABA Antagonists
Serotonin Antagonists

Suppliers and Packaging for NDA: 206433

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOZAPINE	clozapine	TABLET;ORAL	206433	ANDA	Major Pharmaceuticals	0904-7087	0904-7087-61	100 BLISTER PACK in 1 CARTON (0904-7087-61) / 1 TABLET in 1 BLISTER PACK
CLOZAPINE	clozapine	TABLET;ORAL	206433	ANDA	Major Pharmaceuticals	0904-7088	0904-7088-61	100 BLISTER PACK in 1 CARTON (0904-7088-61) / 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Nov 29, 2016	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Nov 29, 2016	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Nov 29, 2016	TE:	AB	RLD:	No

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