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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 two suppliers. 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-four suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the carbamazepine profile page.

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)

Summary for product number 001

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

Expired Orange Book Patents for NDA: 018927

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
TEGRETOL
carbamazepine
SUSPENSION;ORAL018927-001Dec 18, 19874,409,212► subscribe
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