Details for New Drug Application (NDA): 214404
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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 214404
Tradename: | CLOBAZAM |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | clobazam |
Patents: | 0 |
Pharmacology for NDA: 214404
Mechanism of Action | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inducers |
Suppliers and Packaging for NDA: 214404
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLOBAZAM | clobazam | SUSPENSION;ORAL | 214404 | ANDA | Aurobindo Pharma Limited | 59651-401 | 59651-401-12 | 1 BOTTLE in 1 CARTON (59651-401-12) / 120 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 2.5MG/ML | ||||
Approval Date: | Mar 24, 2022 | TE: | AB | RLD: | No |
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