Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 005856
Company: ABBVIE

• Medication Guide

Products on NDA 5856

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

Labels for NDA 005856

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/06/2012	SUPPL-21	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/005856s021lbl.pdf
06/06/2012	SUPPL-21	REMS-Proposal	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/005856s021lbl.pdf