Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077555
Company: SUN PHARM INDS

Products on ANDA 077555

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE	2MG	TABLET;ORAL	Prescription	AB	No	No
TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE	4MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077555

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/04/2011	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/077555s000ltr.pdf

Therapeutic Equivalents for ANDA 077555

TIAGABINE HYDROCHLORIDE

TABLET;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GABITRIL	TIAGABINE HYDROCHLORIDE	2MG	TABLET;ORAL	Prescription	Yes	AB	020646	CEPHALON
TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE	2MG	TABLET;ORAL	Prescription	No	AB	214816	MSN
TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE	2MG	TABLET;ORAL	Prescription	No	AB	077555	SUN PHARM INDS

TABLET;ORAL; 4MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GABITRIL	TIAGABINE HYDROCHLORIDE	4MG	TABLET;ORAL	Prescription	Yes	AB	020646	CEPHALON
TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE	4MG	TABLET;ORAL	Prescription	No	AB	214816	MSN
TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE	4MG	TABLET;ORAL	Prescription	No	AB	077555	SUN PHARM INDS