Details for New Drug Application (NDA): 213039
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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 213039
Tradename: | CLOBAZAM |
Applicant: | Alkem Labs Ltd |
Ingredient: | clobazam |
Patents: | 0 |
Pharmacology for NDA: 213039
Mechanism of Action | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inducers |
Suppliers and Packaging for NDA: 213039
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLOBAZAM | clobazam | SUSPENSION;ORAL | 213039 | ANDA | Ascend Laboratories, LLC | 67877-658 | 67877-658-61 | 1 BOTTLE in 1 CARTON (67877-658-61) / 120 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 2.5MG/ML | ||||
Approval Date: | May 6, 2021 | TE: | AB | RLD: | No |
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