Details for New Drug Application (NDA): 076729

NDA 076729 describes TERIL, which is a drug marketed by Taro and is included in two NDAs. It is available from two suppliers. Additional details are available on the TERIL profile page.

The generic ingredient in TERIL 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 076729

Tradename:	TERIL
Applicant:	Taro
Ingredient:	carbamazepine
Patents:	0

Pharmacology for NDA: 076729

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 076729

Analgesics, Non-Narcotic

Anticonvulsants

Antimanic Agents

Cytochrome P-450 CYP3A Inducers

Suppliers and Packaging for NDA: 076729

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TERIL	carbamazepine	SUSPENSION;ORAL	076729	ANDA	Major Pharmaceuticals	0904-7116	0904-7116-01	30 CUP in 1 CASE (0904-7116-01) / 10 mL in 1 CUP (0904-7116-66)
TERIL	carbamazepine	SUSPENSION;ORAL	076729	ANDA	Taro Pharmaceuticals U.S.A., Inc.	51672-4047	51672-4047-9	450 mL in 1 BOTTLE (51672-4047-9)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	100MG/5ML
Approval Date:	Sep 20, 2004	TE:	AB	RLD:	No

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