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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
US Department of Justice
Fish and Richardson
Harvard Business School
Federal Trade Commission

Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201824

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NDA 201824 describes CLOZAPINE, which is a drug marketed by Barr Labs Inc, Mylan Pharms Inc, Teva Pharms Usa, Accord Hlthcare, Aurobindo Pharma Ltd, Ivax Sub Teva Pharms, Mayne Pharma, Mylan, Par Pharm, Sandoz, Sun Pharm Inds Inc, and Zydus Pharms Usa Inc, 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. Sixteen suppliers are listed for this compound. Additional details are available on the clozapine profile page.
Summary for 201824
Applicant:Mylan Pharms Inc
Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details
Pharmacology for NDA: 201824
Medical Subject Heading (MeSH) Categories for 201824
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 N 0378-3813-01
CLOZAPINE clozapine TABLET, ORALLY DISINTEGRATING;ORAL 201824 ANDA Mylan Pharmaceuticals Inc. 0378-3815 N 0378-3815-01

Profile for product number 002

Approval Date:Sep 15, 2015TE:ABRLD:No

Profile for product number 003

Approval Date:Sep 15, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Boehringer Ingelheim
Express Scripts
Harvard Business School
Queensland Health

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