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. Forty-five suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.

Summary for 018927

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

Pharmacology for NDA: 018927

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 018927

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

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:	RX	Dosage:	SUSPENSION;ORAL			Strength	100MG/5ML
Approval Date:	Dec 18, 1987	TE:	AB	RLD:	Yes

Expired US Patents for NDA 018927

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	TEGRETOL	carbamazepine	SUSPENSION;ORAL	018927-001	Dec 18, 1987	4,409,212	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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