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Last Updated: July 4, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018927

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NDA 018927 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. Thirty-five suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.
Summary for 018927
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 018927
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TEGRETOL carbamazepine SUSPENSION;ORAL 018927 NDA Novartis Pharmaceuticals Corporation 0078-0508 0078-0508-83 450 mL in 1 BOTTLE (0078-0508-83)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength100MG/5ML
Approval Date:Dec 18, 1987TE:ABRLD:Yes

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