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Generated: April 27, 2017

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Details for New Drug Application (NDA): 201824

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NDA 201824 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, Aurobindo Pharma Ltd, Teva Pharms Usa, Sandoz, Par Pharm, and Accord Hlthcare, and is included in twelve 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 twelve drug master file entries for this compound. Sixteen 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: 201824

Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details

Pharmacology for NDA: 201824

Suppliers and Packaging for NDA: 201824

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET, ORALLY DISINTEGRATING;ORAL 201824 ANDA Mylan Pharmaceuticals Inc. 0378-3813 0378-3813-01 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-3813-01)
TABLET, ORALLY DISINTEGRATING;ORAL 201824 ANDA Mylan Pharmaceuticals Inc. 0378-3813 0378-3813-05 500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-3813-05)

Summary for product number 002

Approval Date:Sep 15, 2015TE:ABRLD:No

Summary for product number 003

Approval Date:Sep 15, 2015TE:ABRLD:No

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