Details for New Drug Application (NDA): 075713
✉ Email this page to a colleague
NDA 075713 describes CLOZAPINE, which is a drug marketed by Barr Labs Inc, Mylan, 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 twelve 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 thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. 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. Twelve suppliers are listed for this compound. Additional details are available on the clozapine profile page.
Summary for 075713
| Tradename: | CLOZAPINE |
| Applicant: | Sun Pharm Inds Inc |
| Ingredient: | clozapine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 075713
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLOZAPINE | clozapine | TABLET;ORAL | 075713 | ANDA | Sun Pharmaceutical Industries, Inc. | 57664-211 | 57664-211-13 | 500 TABLET in 1 BOTTLE (57664-211-13) |
| CLOZAPINE | clozapine | TABLET;ORAL | 075713 | ANDA | Sun Pharmaceutical Industries, Inc. | 57664-211 | 57664-211-88 | 100 TABLET in 1 BOTTLE (57664-211-88) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Nov 15, 2002 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Nov 15, 2002 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Aug 19, 2005 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
