Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077827
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXANDROLONE OXANDROLONE 2.5MG TABLET;ORAL Prescription AB No No
OXANDROLONE OXANDROLONE 10MG TABLET;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/22/2007 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
12/31/2007 SUPPL-1 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077827s001ltr.pdf

OXANDROLONE

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXANDROLONE OXANDROLONE 2.5MG TABLET;ORAL Prescription No AB 077827 PAR PHARM
OXANDROLONE OXANDROLONE 2.5MG TABLET;ORAL Prescription No AB 076761 UPSHER SMITH LABS

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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