Details for New Drug Application (NDA): 214328
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The generic ingredient in CARBAMAZEPINE is carbamazepine. There are twenty-seven drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.
Summary for 214328
Tradename: | CARBAMAZEPINE |
Applicant: | Rk Pharma |
Ingredient: | carbamazepine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 214328
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CARBAMAZEPINE | carbamazepine | TABLET;ORAL | 214328 | ANDA | VGYAAN Pharmaceuticals LLC | 72664-218 | 72664-218-01 | 100 TABLET in 1 BOTTLE (72664-218-01) |
CARBAMAZEPINE | carbamazepine | TABLET;ORAL | 214328 | ANDA | VGYAAN Pharmaceuticals LLC | 72664-218 | 72664-218-10 | 1000 TABLET in 1 BOTTLE (72664-218-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Aug 16, 2021 | TE: | RLD: | No |
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