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Last Updated: April 2, 2020

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, Teva Pharms Usa, Accord Hlthcare, Aurobindo Pharma Ltd, Ivax Sub Teva Pharms, Mayne Pharma, Par Pharm, Sandoz, Sun Pharm Inds Inc, and Zydus Pharms, and is included in thirteen 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 074949
Tradename:CLOZAPINE
Applicant:Ivax Sub Teva Pharms
Ingredient:clozapine
Patents:0
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 0093-4359-01 100 TABLET in 1 BOTTLE (0093-4359-01)
CLOZAPINE clozapine TABLET;ORAL 074949 ANDA Teva Pharmaceuticals USA, Inc. 0093-4359 0093-4359-05 500 TABLET in 1 BOTTLE (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:RLD:No

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