Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 005856
Company: ABBVIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIDIONE TRIMETHADIONE 200MG/5ML SOLUTION;ORAL Discontinued None No No
TRIDIONE TRIMETHADIONE 300MG CAPSULE;ORAL Discontinued None No No
TRIDIONE TRIMETHADIONE 150MG TABLET;ORAL Discontinued None Yes 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
01/25/1946 ORIG-1 Approval UNKNOWN

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/07/2016 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

06/06/2012 SUPPL-21 REMS-Proposal, Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/005856s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/005856s021ltr.pdf
04/23/2009 SUPPL-20 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/005856s020ltr.pdf
09/26/2002 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

12/10/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

07/22/1997 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

10/28/1983 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

02/11/1982 SUPPL-15 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/22/1981 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/24/1979 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/06/1978 SUPPL-9 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/07/1979 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1975 SUPPL-5 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
06/06/2012 SUPPL-21 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/005856s021lbl.pdf
06/06/2012 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/005856s021lbl.pdf

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