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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 075162


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NDA 075162 describes CLOZAPINE, which is a drug marketed by Barr Labs Inc, Mylan, Teva Pharms Usa, Accord Hlthcare, Aurobindo Pharma, Dr Reddys Labs Sa, Ivax Sub Teva Pharms, Par Pharm, Sandoz, Sun Pharm Inds Inc, and Zydus Pharms, and is included in thirteen NDAs. It is available from thirteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the clozapine profile page.
Summary for 075162
Tradename:CLOZAPINE
Applicant:Par Pharm
Ingredient:clozapine
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 075162

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG
Approval Date:Apr 26, 2005TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Apr 26, 2005TE:RLD:No

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