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Details for New Drug Application (NDA): 203039

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NDA 203039 describes CLOZAPINE, which is a drug marketed by Mayne Pharma, Barr Labs Inc, Ivax Sub Teva Pharms, Sun Pharm Inds Inc, Mylan, Mylan Pharms Inc, Teva Pharms Usa, Sandoz, Par Pharm, and Accord Hlthcare, and is included in eleven 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 twelve drug master file entries for this compound. Fourteen suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the clozapine profile page.

Summary for NDA: 203039

Teva Pharms Usa
Therapeutic Class:Antipsychotics

Summary for product number 001

Approval Date:Nov 25, 2015TE:ABRLD:No

Summary for product number 002

Approval Date:Nov 25, 2015TE:ABRLD:No

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