APPLICATION
ANDA202985
TYPE
ANDA
ORIGINAL APPROVAL
2023-03-29
LATEST ACTION
2024-08-19
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
ESTRADIOLPrescription
ESTRADIOL 0.075MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
ESTRADIOLPrescription
ESTRADIOL 0.05MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
ESTRADIOLPrescription
ESTRADIOL 0.025MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
ESTRADIOLPrescription
ESTRADIOL 0.1MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
ESTRADIOLPrescription
ESTRADIOL 0.06MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
ESTRADIOLPrescription
ESTRADIOL 0.0375MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
Approval history
2024-08-19Labeling · Supplement 1 · standardAP
2023-03-29UNKNOWN · OriginalAP
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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