Drugs@FDA: FDA Approved Drug Products

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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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/30/1997 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020646_gabitril_toc.cfm
Supplements
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)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020646s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020646Orig1s021ltr.pdf
01/25/2012 SUPPL-20 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020646s020ltr.pdf
11/04/2015 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020646s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020646Orig1s018ltr.pdf
10/11/2010 SUPPL-17 REMS-Proposal, Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020646s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020646s017ltr.pdf
04/23/2009 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020646s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020646s016ltr.pdf
11/29/2005 SUPPL-15 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020646s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020646s015ltr.pdf
02/14/2005 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020646s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020646s014ltr.pdf
10/03/2001 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/03/2001 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/27/2001 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/16/2000 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/17/2000 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

08/23/1999 SUPPL-6 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/16/1999 SUPPL-5 Labeling

Label is not available on this site.

04/16/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/31/1998 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

05/08/1998 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/09/1997 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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

GABITRIL

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

TABLET;ORAL; 12MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GABITRIL TIAGABINE HYDROCHLORIDE 12MG TABLET;ORAL Prescription Yes AB 020646 CEPHALON
TIAGABINE HYDROCHLORIDE TIAGABINE HYDROCHLORIDE 12MG TABLET;ORAL Prescription No AB 208181 AMNEAL PHARMS CO
TIAGABINE HYDROCHLORIDE TIAGABINE HYDROCHLORIDE 12MG TABLET;ORAL Prescription No AB 206857 WILSHIRE PHARMS INC

TABLET;ORAL; 16MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GABITRIL TIAGABINE HYDROCHLORIDE 16MG TABLET;ORAL Prescription Yes AB 020646 CEPHALON
TIAGABINE HYDROCHLORIDE TIAGABINE HYDROCHLORIDE 16MG TABLET;ORAL Prescription No AB 208181 AMNEAL PHARMS CO
TIAGABINE HYDROCHLORIDE TIAGABINE HYDROCHLORIDE 16MG TABLET;ORAL Prescription No AB 206857 WILSHIRE PHARMS INC

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

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