Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 008719
Company: VALEANT PHARM INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVO-DROMORAN LEVORPHANOL TARTRATE 2MG/ML INJECTABLE;INJECTION 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
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
12/05/2000 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

04/24/2000 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

07/13/1999 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

01/26/1998 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

08/15/1994 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

08/15/1994 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

09/27/1989 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/09/1989 SUPPL-25 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/03/1985 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

10/23/1985 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/26/1985 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

06/07/1984 SUPPL-21 Labeling

Label is not available on this site.

09/20/1983 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

04/19/1983 SUPPL-19 Labeling

Label is not available on this site.

05/16/1983 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

03/03/1982 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/08/1981 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/27/1981 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/15/1978 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/07/1978 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

12/19/1991 SUPPL-8 Efficacy-New Indication

Label is not available on this site.

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