Details for New Drug Application (NDA): 090308
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NDA 090308 describes CLOZAPINE, which is a drug marketed by Aurobindo Pharma, Barr Labs Inc, Mylan, Accord Hlthcare, Dr Reddys Labs Sa, Ivax Sub Teva Pharms, Par Pharm, Sandoz, Sun Pharm Inds Inc, and Zydus Pharms, and is included in thirteen NDAs. It is available from nine 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. Eleven 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. Eleven suppliers are listed for this compound. Additional details are available on the clozapine profile page.
Summary for 090308
| Tradename: | CLOZAPINE |
| Applicant: | Barr Labs Inc |
| Ingredient: | clozapine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 090308
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLOZAPINE | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 090308 | 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 | 090308 | 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 | 25MG | ||||
| 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 | 100MG | ||||
| Approval Date: | Nov 25, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 12.5MG | ||||
| Approval Date: | Apr 9, 2018 | TE: | AB | RLD: | No | ||||
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