Details for New Drug Application (NDA): 216404
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The generic ingredient in CARBAMAZEPINE is carbamazepine. There are twenty-seven drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.
Summary for 216404
Tradename: | CARBAMAZEPINE |
Applicant: | Novast Labs |
Ingredient: | carbamazepine |
Patents: | 0 |
Suppliers and Packaging for NDA: 216404
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CARBAMAZEPINE | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 216404 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-257 | 50742-257-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50742-257-01) |
CARBAMAZEPINE | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 216404 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-258 | 50742-258-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50742-258-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 100MG | ||||
Approval Date: | Dec 2, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 200MG | ||||
Approval Date: | Dec 2, 2022 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 400MG | ||||
Approval Date: | Dec 2, 2022 | TE: | AB | RLD: | No |
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