Details for New Drug Application (NDA): 210039
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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.
Pharmacology for NDA: 210039
Mechanism of Action | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inducers |
Suppliers and Packaging for NDA: 210039
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLOBAZAM | clobazam | SUSPENSION;ORAL | 210039 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1535 | 69238-1535-2 | 1 BOTTLE, GLASS in 1 CARTON (69238-1535-2) / 120 mL in 1 BOTTLE, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 2.5MG/ML | ||||
Approval Date: | Oct 22, 2018 | TE: | AB | RLD: | No |
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