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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021417
Company: WYETH PHARMS INC

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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/16/2003 ORIG-1 Approval Type 6 - New Indication (no longer used) STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-417_Premarin_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21417ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-417_Premarin.cfm

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/16/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-417_Premarin_prntlbl.pdf
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