Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012697
Company: VALEANT PHARM INTL

Products on NDA 012697

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRISORALEN	TRIOXSALEN	5MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012697

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/24/1964	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/23/1997	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
08/09/1996	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
01/14/1985	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
04/16/1984	SUPPL-11	Labeling		Label is not available on this site.
08/01/1980	SUPPL-10	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
11/26/1979	SUPPL-9	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/09/1976	SUPPL-8	Labeling		Label is not available on this site.
07/09/1976	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.