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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Chubb
Johnson and Johnson
Deloitte
Queensland Health
Medtronic
US Department of Justice
Accenture
Federal Trade Commission

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203807

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NDA 203807 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. Fifteen suppliers are listed for this compound. Additional details are available on the clozapine profile page.
Summary for 203807
Tradename:CLOZAPINE
Applicant:Mayne Pharma
Ingredient:clozapine
Patents:0
Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details
Pharmacology for NDA: 203807
Medical Subject Heading (MeSH) Categories for 203807
Suppliers and Packaging for NDA: 203807
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOZAPINE clozapine TABLET;ORAL 203807 ANDA Actavis Pharma, Inc. 0591-2528 N 0591-2528-05
CLOZAPINE clozapine TABLET;ORAL 203807 ANDA Actavis Pharma, Inc. 0591-2528 N 0591-2528-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Sep 17, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Sep 17, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Aug 22, 2017TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
Express Scripts
Citi
Merck
Deloitte
Colorcon
Baxter
AstraZeneca

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