Details for New Drug Application (NDA): 077555

NDA 077555 describes TIAGABINE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms Co, MSN, Sun Pharm Inds, and Wilshire Pharms Inc, and is included in four NDAs. It is available from four suppliers. Additional details are available on the TIAGABINE HYDROCHLORIDE profile page.

The generic ingredient in TIAGABINE HYDROCHLORIDE is tiagabine hydrochloride. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the tiagabine hydrochloride profile page.

Summary for 077555

Tradename:	TIAGABINE HYDROCHLORIDE
Applicant:	Sun Pharm Inds
Ingredient:	tiagabine hydrochloride
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 077555

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 077555

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TIAGABINE HYDROCHLORIDE	tiagabine hydrochloride	TABLET;ORAL	077555	ANDA	Sun Pharmaceutical Industries, Inc.	62756-200	62756-200-18	1000 TABLET, FILM COATED in 1 BOTTLE (62756-200-18)
TIAGABINE HYDROCHLORIDE	tiagabine hydrochloride	TABLET;ORAL	077555	ANDA	Sun Pharmaceutical Industries, Inc.	62756-200	62756-200-83	30 TABLET, FILM COATED in 1 BOTTLE (62756-200-83)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Nov 4, 2011	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	4MG
Approval Date:	Nov 4, 2011	TE:	AB	RLD:	No

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