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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020527
Company: WYETH PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREMPHASE 14/14 ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE 0.625MG,0.625MG;N/A,5MG TABLET;ORAL-28 Prescription None Yes Yes
PREMPRO ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE 0.625MG;2.5MG TABLET;ORAL-28 Prescription None Yes Yes
PREMPRO ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE 0.625MG;5MG TABLET;ORAL-28 Prescription None Yes Yes
PREMPRO ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE 0.45MG;1.5MG TABLET;ORAL-28 Prescription None Yes Yes
PREMPRO ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE 0.3MG;1.5MG TABLET;ORAL-28 Prescription None Yes Yes

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
04/22/2025 SUPPL-67 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020527s067lbl.pdf
02/15/2024 SUPPL-68 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020527s068lbl.pdf
11/01/2017 SUPPL-65 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020527s065lbl.pdf
08/31/2015 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020527s062lbl.pdf
02/02/2012 SUPPL-56 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020527s051s052s054s056lbl.pdf
02/02/2012 SUPPL-54 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020527s051s052s054s056lbl.pdf
02/02/2012 SUPPL-52 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020527s051s052s054s056lbl.pdf
02/02/2012 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020527s051s052s054s056lbl.pdf
12/30/2009 SUPPL-45 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020527s045lbl.pdf
05/18/2009 SUPPL-46 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020527s046lbl.pdf
03/03/2008 SUPPL-43 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020527s043lbl.pdf
07/27/2006 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020527s037lbl.pdf
06/30/2005 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020527s036lbl.pdf
04/20/2004 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020527S034035lbl.pdf
04/20/2004 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020527S034035lbl.pdf
06/04/2003 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20527se1-024,slr026,slr031_prempro_lbl.pdf
06/04/2003 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20527se1-024,slr026,slr031_prempro_lbl.pdf
06/04/2003 SUPPL-24 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20527se1-024,slr026,slr031_prempro_lbl.pdf
03/12/2003 SUPPL-17 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020527s017lbl.pdf
01/07/2003 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20527s30bl.pdf
11/27/2002 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20527slr029_prempro_lbl.pdf
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