Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

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

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English