U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 011839
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROVERA MEDROXYPROGESTERONE ACETATE 2.5MG TABLET;ORAL Prescription AB Yes No
PROVERA MEDROXYPROGESTERONE ACETATE 5MG TABLET;ORAL Prescription AB Yes No
PROVERA MEDROXYPROGESTERONE ACETATE 10MG TABLET;ORAL Prescription AB Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/07/2015 SUPPL-80 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011839s079s080lbl.pdf
05/07/2015 SUPPL-79 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011839s079s080lbl.pdf
09/28/2007 SUPPL-71 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011839s071lbl.pdf
Back to Top