Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 008720
Company: VALEANT PHARM INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVO-DROMORAN LEVORPHANOL TARTRATE 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
01/08/1953 ORIG-1 Approval Type 3 - New Dosage Form 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
09/03/2004 SUPPL-16 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/08720s016ltr.pdf
01/26/1998 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/1986 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

02/03/1983 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

03/03/1981 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

06/25/1979 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

02/07/1978 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/19/1991 SUPPL-6 Efficacy-New Indication

Label is not available on this site.

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