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Drugs@FDA: FDA-Approved Drugs

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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

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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