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TIAGABINE HYDROCHLORIDE

ANDA

TIAGABINE HYDROCHLORIDE | A077555 | SUN PHARMACEUTICAL INDUSTRIES LTD

2 strengths0 unique patents0 unique exclusivities

API Supply Chain3 active DMFs3 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

SUN PHARMACEUTICAL INDUSTRIES LTDTIAGABINE HYDROCHLORIDE USP

DMF 179782005

CHEMWERTH INCTIAGABINE HYDROCHLORIDE

DMF 220332008

MSN LIFE SCIENCES PRIVATE LTDTIAGABINE HYDROCHLORIDE USP

DMF 334942018

RANBAXY LABORATORIES LTDInactiveTIAGABINE HYDROCHLORIDE USP

DMF 189342005

UNICHEM LABORATORIES LTDInactiveTIAGABINE HYDROCHLORIDE USP

DMF 272862013

SIGNA SA DE CVInactiveTIAGABINE HYDROCHLORIDE MONOHYDRATE USP

DMF 273802013

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 10, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 2MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 4, 2011

No patent or exclusivity listings for this strength.

#002 — 4MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 4, 2011