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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087222
Company: VALEANT PHARM INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANDROID 5 METHYLTESTOSTERONE 5MG TABLET;BUCCAL 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
12/18/1990 SUPPL-5 Labeling

Label is not available on this site.

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