Details for New Drug Application (NDA): 201824

NDA 201824 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 201824

Tradename:	CLOZAPINE
Applicant:	Mylan
Ingredient:	clozapine
Patents:	0

Pharmacology for NDA: 201824

Medical Subject Heading (MeSH) Categories for 201824

Antipsychotic Agents

GABA Antagonists

Serotonin Antagonists

Suppliers and Packaging for NDA: 201824

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOZAPINE	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	201824	ANDA	Mylan Pharmaceuticals Inc.	0378-3813	0378-3813-01	100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-3813-01)
CLOZAPINE	clozapine	TABLET, ORALLY DISINTEGRATING;ORAL	201824	ANDA	Mylan Pharmaceuticals Inc.	0378-3815	0378-3815-01	100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-3815-01)

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	25MG
Approval Date:	Sep 15, 2015	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	100MG
Approval Date:	Sep 15, 2015	TE:	AB	RLD:	No

Profile for product number 004

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	150MG
Approval Date:	Aug 7, 2023	TE:	AB	RLD:	No

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