Details for New Drug Application (NDA): 211959
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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 211959
Tradename: | CLOBAZAM |
Applicant: | Anda Repository |
Ingredient: | clobazam |
Patents: | 0 |
Pharmacology for NDA: 211959
Mechanism of Action | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inducers |
Suppliers and Packaging for NDA: 211959
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLOBAZAM | clobazam | TABLET;ORAL | 211959 | ANDA | CELLTRION USA, INC. | 72606-003 | 72606-003-01 | 1 BOTTLE in 1 CARTON (72606-003-01) / 100 TABLET in 1 BOTTLE |
CLOBAZAM | clobazam | TABLET;ORAL | 211959 | ANDA | CELLTRION USA, INC. | 72606-004 | 72606-004-01 | 1 BOTTLE in 1 CARTON (72606-004-01) / 100 TABLET in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Dec 9, 2020 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Dec 9, 2020 | TE: | RLD: | No |
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