Details for New Drug Application (NDA): 213110
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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 213110
Tradename: | CLOBAZAM |
Applicant: | Chartwell Molecular |
Ingredient: | clobazam |
Patents: | 0 |
Pharmacology for NDA: 213110
Mechanism of Action | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inducers |
Suppliers and Packaging for NDA: 213110
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLOBAZAM | clobazam | SUSPENSION;ORAL | 213110 | ANDA | Chartwell RX, LLC | 62135-527 | 62135-527-41 | 120 mL in 1 BOTTLE (62135-527-41) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 2.5MG/ML | ||||
Approval Date: | Apr 24, 2020 | TE: | AB | RLD: | No |
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