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Last Updated: April 22, 2024

Details for New Drug Application (NDA): 016608

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NDA 016608 describes TEGRETOL, which is a drug marketed by Novartis and is included in four NDAs. It is available from one supplier. Additional details are available on the TEGRETOL profile page.

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
Formulation / Manufacturing:see details
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:RXDosage:TABLET;ORALStrength200MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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