Details for New Drug Application (NDA): 211449
✉ Email this page to a colleague
The generic ingredient in CLOBAZAM is clobazam. There are ten drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the clobazam profile page.
Summary for 211449
Tradename: | CLOBAZAM |
Applicant: | Zydus Pharms |
Ingredient: | clobazam |
Patents: | 0 |
Pharmacology for NDA: 211449
Mechanism of Action | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inducers |
Suppliers and Packaging for NDA: 211449
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLOBAZAM | clobazam | TABLET;ORAL | 211449 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1325 | 70710-1325-1 | 100 TABLET in 1 BOTTLE (70710-1325-1) |
CLOBAZAM | clobazam | TABLET;ORAL | 211449 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1326 | 70710-1326-1 | 100 TABLET in 1 BOTTLE (70710-1326-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Oct 22, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Oct 22, 2018 | TE: | AB | RLD: | No |
Complete Access Available with Subscription