Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 012697
Company: VALEANT PHARM INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRISORALEN TRIOXSALEN 5MG TABLET;ORAL Discontinued None No 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
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.

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