APPLICATION
NDA021167
TYPE
NDA
ORIGINAL APPROVAL
2000-08-16
LATEST ACTION
2000-08-16
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Prescription, Discontinued
Products
VIVELLEPrescription
ESTRADIOL 0.1MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
VIVELLEPrescription
ESTRADIOL 0.05MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
VIVELLEDiscontinued
ESTRADIOL 0.025MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
VIVELLEDiscontinued
ESTRADIOL 0.075MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
VIVELLEDiscontinued
ESTRADIOL 0.0375MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
Approval history
2000-08-16Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval · Original · standard — Label ↗AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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