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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 004782
Company: WYETH PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREMARIN ESTROGENS, CONJUGATED 1.25MG TABLET;ORAL Prescription AB Yes Yes
PREMARIN ESTROGENS, CONJUGATED 2.5MG TABLET;ORAL Discontinued None No No
PREMARIN ESTROGENS, CONJUGATED 0.3MG TABLET;ORAL Prescription AB Yes No
PREMARIN ESTROGENS, CONJUGATED 0.625MG TABLET;ORAL Prescription AB Yes Yes
PREMARIN ESTROGENS, CONJUGATED 0.9MG TABLET;ORAL Prescription AB Yes Yes
PREMARIN ESTROGENS, CONJUGATED 0.45MG TABLET;ORAL Prescription AB Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
04/22/2025 SUPPL-179 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/004782s179lbl.pdf
02/15/2024 SUPPL-181 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/004782s181lbl.pdf
11/07/2017 SUPPL-176 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/004782s176lbl.pdf
12/03/2014 SUPPL-171 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/004782s171lbl.pdf
10/28/2011 SUPPL-167 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/004782s162s164s167lbl.pdf
10/28/2011 SUPPL-164 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/004782s162s164s167lbl.pdf
10/28/2011 SUPPL-162 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/004782s162s164s167lbl.pdf
03/03/2008 SUPPL-155 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/004782s155lbl.pdf
09/05/2006 SUPPL-147 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/004782s147lbl.pdf
04/24/2006 SUPPL-146 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/004782s146lbl.pdf
11/01/2005 SUPPL-142 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s142lbl.pdf
08/01/2005 SUPPL-141 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s141lbl.pdf
04/07/2005 SUPPL-139 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s138,139lbl.pdf
04/07/2005 SUPPL-138 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s138,139lbl.pdf
08/26/2004 SUPPL-137 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/04782s137lbl.pdf
04/20/2004 SUPPL-136 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/04782S136lbl.pdf
04/20/2004 SUPPL-133 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/04782slr133,136_premarin_lbl.pdf
04/24/2003 SUPPL-130 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/004782s115lbl.pdf
04/24/2003 SUPPL-115 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/004782s115lbl.pdf
01/07/2003 SUPPL-129 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/04782s129lbl.pdf
11/27/2002 SUPPL-128 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/04782slr128_Premarin_lbl.pdf
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