Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021788
Company: TEVA WOMENS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SYNTHETIC CONJUGATED ESTROGENS A ESTROGENS, CONJUGATED SYNTHETIC A 0.625MG/GM CREAM;VAGINAL Discontinued 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
11/28/2008 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021788lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021788s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021788_synthetic_conjugated_estrogens_toc.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/28/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021788lbl.pdf

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