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Generated: June 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074949

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NDA 074949 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. Seventeen suppliers are listed for this compound. Additional details are available on the clozapine profile page.
Summary for 074949
Tradename:CLOZAPINE
Applicant:Ivax Sub Teva Pharms
Ingredient:clozapine
Patents:0
Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details
Pharmacology for NDA: 074949
Medical Subject Heading (MeSH) Categories for 074949
Suppliers and Packaging for NDA: 074949
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOZAPINE clozapine TABLET;ORAL 074949 ANDA Teva Pharmaceuticals USA, Inc. 0093-4359 N 0093-4359-01
CLOZAPINE clozapine TABLET;ORAL 074949 ANDA Teva Pharmaceuticals USA, Inc. 0093-4359 N 0093-4359-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Nov 26, 1997TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Nov 26, 1997TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG
Approval Date:Jul 31, 2003TE:ABRLD:No

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