Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020646
Company: CEPHALON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GABITRIL TIAGABINE HYDROCHLORIDE 4MG TABLET;ORAL Prescription AB Yes Yes
GABITRIL TIAGABINE HYDROCHLORIDE 12MG TABLET;ORAL Prescription AB Yes No
GABITRIL TIAGABINE HYDROCHLORIDE 16MG TABLET;ORAL Prescription AB Yes No
GABITRIL TIAGABINE HYDROCHLORIDE 20MG TABLET;ORAL Discontinued None No No
GABITRIL TIAGABINE HYDROCHLORIDE 2MG TABLET;ORAL Prescription AB Yes No
GABITRIL TIAGABINE HYDROCHLORIDE 6MG TABLET;ORAL Discontinued None No No
GABITRIL TIAGABINE HYDROCHLORIDE 8MG TABLET;ORAL Discontinued None No No
GABITRIL TIAGABINE HYDROCHLORIDE 10MG TABLET;ORAL Discontinued None No No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/09/2016 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020646s021lbl.pdf
11/04/2015 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020646s018lbl.pdf
10/11/2010 SUPPL-17 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020646s017lbl.pdf
10/11/2010 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020646s017lbl.pdf
04/23/2009 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020646s016lbl.pdf
11/29/2005 SUPPL-15 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020646s015lbl.pdf
02/14/2005 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020646s014lbl.pdf

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