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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 212923

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NDA 212923 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 212923

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

Pharmacology for NDA: 212923

Medical Subject Heading (MeSH) Categories for 212923

Antipsychotic Agents
GABA Antagonists
Serotonin Antagonists

Suppliers and Packaging for NDA: 212923

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOZAPINE	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	212923	ANDA	Aurobindo Pharma Limited	59651-260	59651-260-01	100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (59651-260-01)
CLOZAPINE	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	212923	ANDA	Aurobindo Pharma Limited	59651-261	59651-261-01	100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (59651-261-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	12.5MG
Approval Date:	Dec 12, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	25MG
Approval Date:	Dec 12, 2024	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	100MG
Approval Date:	Dec 12, 2024	TE:	AB	RLD:	No

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