Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086450
Company: VALEANT PHARMS NORTH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANDROID 10 METHYLTESTOSTERONE 10MG 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
02/09/1981 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/25/2016 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

05/11/2015 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

06/19/2014 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

10/16/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/16/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/16/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/16/1996 SUPPL-8 Labeling

Label is not available on this site.

10/16/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/16/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/18/1990 SUPPL-5 Labeling

Label is not available on this site.

06/23/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/11/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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