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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 201824


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NDA 201824 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 nine 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. Eleven 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:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength25MG
Approval Date:Sep 15, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength100MG
Approval Date:Sep 15, 2015TE:ABRLD:No

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength150MG
Approval Date:Aug 7, 2023TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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