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Last Updated: April 2, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206433


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NDA 206433 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 206433
Tradename:CLOZAPINE
Applicant:Aurobindo Pharma Ltd
Ingredient:clozapine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206433
Medical Subject Heading (MeSH) Categories for 206433
Suppliers and Packaging for NDA: 206433
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOZAPINE clozapine TABLET;ORAL 206433 ANDA American Health Packaging 60687-404 60687-404-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-404-01) > 1 TABLET in 1 BLISTER PACK (60687-404-11)
CLOZAPINE clozapine TABLET;ORAL 206433 ANDA American Health Packaging 60687-415 60687-415-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-415-01) > 1 TABLET in 1 BLISTER PACK (60687-415-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Nov 29, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Nov 29, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Nov 29, 2016TE:ABRLD:No

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