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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Fuji
Mallinckrodt
Cipla
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Colorcon
McKesson
QuintilesIMS
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US Department of Justice

Generated: December 17, 2017

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, and Sun Pharm Inds Inc, 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. Sixteen suppliers are listed for this compound. Additional details are available on the clozapine profile page.

Summary for 201824

Tradename:1
Applicant:1
Ingredient:1
Patents:0
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 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)

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength25MG
Approval Date:Sep 15, 2015TE:ABRLD:No

Summary for product number 003

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


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Serving leading biopharmaceutical companies globally:

Accenture
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