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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078033
Company: UPSHER SMITH LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXANDROLONE OXANDROLONE 10MG TABLET;ORAL Prescription AB 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
03/22/2007 ORIG-22 Approval

Label is not available on this site.

03/22/2007 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
04/15/2009 SUPPL-4 Labeling

Label is not available on this site.

OXANDROLONE

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXANDROLONE OXANDROLONE 10MG TABLET;ORAL Prescription No AB 077827 PAR PHARM
OXANDROLONE OXANDROLONE 10MG TABLET;ORAL Prescription No AB 078033 UPSHER SMITH LABS
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