Details for New Drug Application (NDA): 016608
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The generic ingredient in TEGRETOL is carbamazepine. There are twenty-seven drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.
Summary for 016608
Tradename: | TEGRETOL |
Applicant: | Novartis |
Ingredient: | carbamazepine |
Patents: | 0 |
Suppliers and Packaging for NDA: 016608
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TEGRETOL | carbamazepine | TABLET;ORAL | 016608 | NDA | Novartis Pharmaceuticals Corporation | 0078-0509 | 0078-0509-05 | 100 TABLET in 1 BOTTLE (0078-0509-05) |
TEGRETOL | carbamazepine | TABLET;ORAL | 016608 | NDA | Novartis Pharmaceuticals Corporation | 0078-0509 | 0078-0509-20 | 60 TABLET in 1 BOTTLE (0078-0509-20) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 016608
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | TEGRETOL | carbamazepine | TABLET;ORAL | 016608-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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