Drugs@FDA: FDA Approved Drug Products

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

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 208181 AMNEAL PHARMS CO
TIAGABINE HYDROCHLORIDE TIAGABINE HYDROCHLORIDE 2MG TABLET;ORAL Prescription No AB 077555 SUN PHARM INDS
TIAGABINE HYDROCHLORIDE TIAGABINE HYDROCHLORIDE 2MG TABLET;ORAL Prescription No AB 206857 WILSHIRE PHARMS INC

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 208181 AMNEAL PHARMS CO
TIAGABINE HYDROCHLORIDE TIAGABINE HYDROCHLORIDE 4MG TABLET;ORAL Prescription No AB 077555 SUN PHARM INDS
TIAGABINE HYDROCHLORIDE TIAGABINE HYDROCHLORIDE 4MG TABLET;ORAL Prescription No AB 206857 WILSHIRE PHARMS INC

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