Last Updated: May 11, 2026

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

Tradename:	TEGRETOL
Applicant:	Novartis
Ingredient:	carbamazepine
Patents:	0

Pharmacology for NDA: 016608

Mechanism of Action	Cytochrome P450 1A2 Inducers Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Medical Subject Heading (MeSH) Categories for 016608

Analgesics, Non-Narcotic
Anticonvulsants
Antimanic Agents
Cytochrome P-450 CYP3A Inducers

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

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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	4,409,212	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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