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Last Updated: September 26, 2020

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Details for New Drug Application (NDA): 090308

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NDA 090308 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 090308
Tradename:CLOZAPINE
Applicant:Barr Labs Inc
Ingredient:clozapine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090308
Medical Subject Heading (MeSH) Categories for 090308
Suppliers and Packaging for NDA: 090308
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOZAPINE clozapine TABLET, ORALLY DISINTEGRATING;ORAL 090308 ANDA Teva Pharmaceuticals USA, Inc. 0093-5416 0093-5416-01 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0093-5416-01)
CLOZAPINE clozapine TABLET, ORALLY DISINTEGRATING;ORAL 090308 ANDA Teva Pharmaceuticals USA, Inc. 0093-5417 0093-5417-01 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0093-5417-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength25MG
Approval Date:Nov 25, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength100MG
Approval Date:Nov 25, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength12.5MG
Approval Date:Apr 9, 2018TE:RLD:No

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