Details for New Drug Application (NDA): 070541

NDA 070541 describes EPITOL, which is a drug marketed by Teva and is included in two NDAs. It is available from two suppliers. Additional details are available on the EPITOL profile page.

The generic ingredient in EPITOL 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 070541

Tradename:	EPITOL
Applicant:	Teva
Ingredient:	carbamazepine
Patents:	0

Pharmacology for NDA: 070541

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 070541

Analgesics, Non-Narcotic

Anticonvulsants

Antimanic Agents

Cytochrome P-450 CYP3A Inducers

Suppliers and Packaging for NDA: 070541

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EPITOL	carbamazepine	TABLET;ORAL	070541	ANDA	Teva Pharmaceuticals USA, Inc.	0093-0090	0093-0090-01	100 TABLET in 1 BOTTLE (0093-0090-01)
EPITOL	carbamazepine	TABLET;ORAL	070541	ANDA	Teva Pharmaceuticals USA, Inc.	0093-0109	0093-0109-01	100 TABLET in 1 BOTTLE (0093-0109-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Sep 17, 1986	TE:	AB	RLD:	No

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