Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086101
Company: VALEANT PHARMS NORTH

• Other Important Information from FDA

Products on ANDA 086101

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SECONAL SODIUM	SECOBARBITAL SODIUM	50MG	CAPSULE;ORAL	Discontinued	None	No	No
SECONAL SODIUM	SECOBARBITAL SODIUM	100MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 086101

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/03/1983	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/08/2018	SUPPL-23	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/20/2008	SUPPL-21	Labeling		Label is not available on this site.
06/27/2007	SUPPL-20	Labeling		Label is not available on this site.
09/25/2003	SUPPL-17	Labeling		Label is not available on this site.
08/20/2003	SUPPL-15	Labeling		Label is not available on this site.
09/09/1998	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
03/17/1998	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
07/07/1995	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
03/28/1991	SUPPL-8	Labeling		Label is not available on this site.
10/03/1990	SUPPL-6	Labeling		Label is not available on this site.
08/02/1989	SUPPL-5	Labeling		Label is not available on this site.
09/09/1988	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
07/03/1986	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
07/03/1986	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
08/24/1988	SUPPL-1	Bioequivalence		Label is not available on this site.