Details for New Drug Application (NDA): 206433
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The generic ingredient in CLOZAPINE is clozapine. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the clozapine profile page.
Summary for 206433
Tradename: | CLOZAPINE |
Applicant: | Aurobindo Pharma |
Ingredient: | clozapine |
Patents: | 0 |
Suppliers and Packaging for NDA: 206433
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLOZAPINE | clozapine | TABLET;ORAL | 206433 | ANDA | Major Pharmaceuticals | 0904-7087 | 0904-7087-61 | 100 BLISTER PACK in 1 CARTON (0904-7087-61) / 1 TABLET in 1 BLISTER PACK |
CLOZAPINE | clozapine | TABLET;ORAL | 206433 | ANDA | Major Pharmaceuticals | 0904-7088 | 0904-7088-61 | 100 BLISTER PACK in 1 CARTON (0904-7088-61) / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Nov 29, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Nov 29, 2016 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Nov 29, 2016 | TE: | AB | RLD: | No |
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