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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 005856
Company: ABBVIE

Medication Guide

Products on NDA 005856

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 005856

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	Labeling, REMS-Proposal	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.

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

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