Details for New Drug Application (NDA): 211711
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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 211711
Tradename: | CLOBAZAM |
Applicant: | Micro Labs |
Ingredient: | clobazam |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 211711
Mechanism of Action | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inducers |
Suppliers and Packaging for NDA: 211711
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLOBAZAM | clobazam | TABLET;ORAL | 211711 | ANDA | Micro Labs Limited | 42571-315 | 42571-315-01 | 100 TABLET in 1 BOTTLE (42571-315-01) |
CLOBAZAM | clobazam | TABLET;ORAL | 211711 | ANDA | Micro Labs Limited | 42571-315 | 42571-315-05 | 500 TABLET in 1 BOTTLE (42571-315-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Jan 30, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Jan 30, 2019 | TE: | AB | RLD: | No |
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