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New Drug Application (NDA): 020264
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEGACE MEGESTROL ACETATE 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUSPENSION;ORAL Discontinued None Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/18/2019 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020264s021lbl.pdf
04/08/2012 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020264s017lbl.pdf
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