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Drugs@FDA: FDA-Approved Drugs

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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
02/15/2024 SUPPL-83 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/011839s083lbl.pdf
09/18/2023 SUPPL-78 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/011839Orig1s078lbl.pdf
09/18/2023 SUPPL-78 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/011839Orig1s078lbl.pdf
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
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