Details for New Drug Application (NDA): 213404
NDA 213404 describes CLOBAZAM, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Bionpharma, Chartwell Molecular, Hetero Labs Ltd Iii, Hikma, Lupin, Pharmobedient, Taro, Teva Pharms Usa, Upsher Smith Labs, Vistapharm Llc, Amneal Pharms Co, Apotex, Chartwell Rx, Micro Labs, MSN, Novitium Pharma, Pharmazone, and Zydus Pharms, and is included in thirty-one NDAs. It is available from sixteen suppliers. Additional details are available on the CLOBAZAM profile page.
The generic ingredient in CLOBAZAM is clobazam. There is one drug master file entry for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the clobazam profile page.
The generic ingredient in CLOBAZAM is clobazam. There is one drug master file entry for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the clobazam profile page.
Pharmacology for NDA: 213404
| Mechanism of Action | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inducers |
Suppliers and Packaging for NDA: 213404
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLOBAZAM | clobazam | TABLET;ORAL | 213404 | ANDA | Novadoz Pharmaceuticals LLC | 72205-047 | 72205-047-91 | 1 BOTTLE in 1 CARTON (72205-047-91) / 100 TABLET in 1 BOTTLE |
| CLOBAZAM | clobazam | TABLET;ORAL | 213404 | ANDA | Novadoz Pharmaceuticals LLC | 72205-048 | 72205-048-91 | 1 BOTTLE in 1 CARTON (72205-048-91) / 100 TABLET in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | May 11, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | May 11, 2021 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
