Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021167
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIVELLE ESTRADIOL 0.0375MG/24HR FILM, EXTENDED RELEASE; TRANSDERMAL Discontinued None No No
VIVELLE ESTRADIOL 0.05MG/24HR FILM, EXTENDED RELEASE; TRANSDERMAL Prescription None No No
VIVELLE ESTRADIOL 0.075MG/24HR FILM, EXTENDED RELEASE; TRANSDERMAL Discontinued None No No
VIVELLE ESTRADIOL 0.1MG/24HR FILM, EXTENDED RELEASE; TRANSDERMAL Prescription None No No
VIVELLE ESTRADIOL 0.025MG/24HR FILM, EXTENDED RELEASE; TRANSDERMAL 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
08/16/2000 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20323S23lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20323S23ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-167_20-323S23_Vivelle.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/16/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20323S23lbl.pdf

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