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Generated: December 17, 2017

DrugPatentWatch Database Preview

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 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 076809

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antipsychotics
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 0093-4404-93 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0093-4404-93) > 1 TABLET in 1 BLISTER PACK (0093-4404-19)
CLOZAPINE clozapine TABLET;ORAL 076809 ANDA Teva Pharmaceuticals USA, Inc. 0093-4404 0093-4404-01 100 TABLET in 1 BOTTLE (0093-4404-01)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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