Details for New Drug Application (NDA): 075417
✉ Email this page to a colleague
NDA 075417 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.
Suppliers and Packaging for NDA: 075417
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLOZAPINE | clozapine | TABLET;ORAL | 075417 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0825 | 0378-0825-01 | 100 TABLET in 1 BOTTLE, PLASTIC (0378-0825-01) |
| CLOZAPINE | clozapine | TABLET;ORAL | 075417 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0860 | 0378-0860-01 | 100 TABLET in 1 BOTTLE, PLASTIC (0378-0860-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | May 27, 1999 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | May 27, 1999 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
| Approval Date: | Apr 15, 2010 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
