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Last Updated: April 1, 2025

Details for New Drug Application (NDA): 206857

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NDA 206857 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 three 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. Four suppliers are listed for this compound. Additional details are available on the tiagabine hydrochloride profile page.

Summary for 206857

Tradename:	TIAGABINE HYDROCHLORIDE
Applicant:	Wilshire Pharms Inc
Ingredient:	tiagabine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Oct 13, 2017	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	4MG
Approval Date:	Oct 13, 2017	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	12MG
Approval Date:	Oct 13, 2017	TE:		RLD:	No

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