Details for New Drug Application (NDA): 203039
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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 203039
Tradename: | CLOZAPINE |
Applicant: | Teva Pharms Usa |
Ingredient: | clozapine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 203039
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLOZAPINE | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 203039 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-5376 | 0093-5376-01 | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0093-5376-01) |
CLOZAPINE | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 203039 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-5376 | 0093-5376-84 | 48 BLISTER PACK in 1 CARTON (0093-5376-84) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-5376-19) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 150MG | ||||
Approval Date: | Nov 25, 2015 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 200MG | ||||
Approval Date: | Nov 25, 2015 | TE: | AB | RLD: | No |
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