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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202873

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NDA 202873 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 202873

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details

Pharmacology for NDA: 202873

Medical Subject Heading (MeSH) Categories for 202873

Suppliers and Packaging for NDA: 202873

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOZAPINE clozapine TABLET;ORAL 202873 ANDA Accord Healthcare Inc. 16729-141 16729-141-16 500 TABLET in 1 BOTTLE (16729-141-16)
CLOZAPINE clozapine TABLET;ORAL 202873 ANDA Accord Healthcare Inc. 16729-141 16729-141-01 100 TABLET in 1 BOTTLE (16729-141-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Nov 25, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Nov 25, 2015TE:ABRLD:No


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