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Last Updated: September 26, 2020

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Details for New Drug Application (NDA): 076809

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NDA 076809 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 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. Sixteen suppliers are listed for this compound. Additional details are available on the clozapine profile page.
Summary for 076809
Tradename:CLOZAPINE
Applicant:Ivax Sub Teva Pharms
Ingredient:clozapine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076809
Medical Subject Heading (MeSH) Categories for 076809
Suppliers and Packaging for NDA: 076809
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOZAPINE clozapine TABLET;ORAL 076809 ANDA Teva Pharmaceuticals USA, Inc. 0093-4404 0093-4404-01 100 TABLET in 1 BOTTLE (0093-4404-01)
CLOZAPINE clozapine TABLET;ORAL 076809 ANDA Teva Pharmaceuticals USA, Inc. 0093-4404 0093-4404-05 500 TABLET in 1 BOTTLE (0093-4404-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Dec 16, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Dec 16, 2005TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Dec 16, 2005TE:ABRLD:No

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