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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009048
Company: VALEANT PHARM INTL

Products on NDA 009048

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
8-MOP	METHOXSALEN	10MG	CAPSULE;ORAL	Discontinued	None	Yes	No
OXSORALEN	METHOXSALEN	1%	LOTION;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 009048

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/03/1954	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/30/2015	SUPPL-48	Manufacturing (CMC)		Label is not available on this site.
07/28/2015	SUPPL-47	Manufacturing (CMC)		Label is not available on this site.
09/20/2013	SUPPL-46	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
03/22/2013	SUPPL-45	Manufacturing (CMC)		Label is not available on this site.
10/31/2001	SUPPL-40	Manufacturing (CMC)-Control		Label is not available on this site.
04/05/2000	SUPPL-38	Manufacturing (CMC)-Control		Label is not available on this site.
03/26/2003	SUPPL-37	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09048slr037_methoxsalen_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/09048slr037ltr.pdf
04/07/1998	SUPPL-36	Manufacturing (CMC)-Control		Label is not available on this site.
03/16/1998	SUPPL-35	Manufacturing (CMC)		Label is not available on this site.
09/23/1997	SUPPL-34	Manufacturing (CMC)-Control		Label is not available on this site.
09/23/1997	SUPPL-33	Manufacturing (CMC)-Control		Label is not available on this site.
01/25/1996	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
03/23/1988	SUPPL-30	Efficacy-New Indication		Label is not available on this site.
04/16/1984	SUPPL-25	Labeling		Label is not available on this site.
04/21/1983	SUPPL-22	Labeling		Label is not available on this site.
05/07/1982	SUPPL-21	Labeling		Label is not available on this site.
05/07/1982	SUPPL-20	Labeling		Label is not available on this site.
04/04/1975	SUPPL-6	Labeling		Label is not available on this site.
11/13/1974	SUPPL-5			Label is not available on this site.

Labels for NDA 009048

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/26/2003	SUPPL-37	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09048slr037_methoxsalen_lbl.pdf

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