APPLICATION
ANDA075182
TYPE
ANDA
ORIGINAL APPROVAL
2000-02-24
LATEST ACTION
2026-06-08
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
ESTRADIOLPrescription
ESTRADIOL 0.06MG/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 0.05MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
ESTRADIOLPrescription
ESTRADIOL 0.0375MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
ESTRADIOLPrescription
ESTRADIOL 0.075MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
Approval history
2026-06-08Labeling · Supplement 30 · standardAP
2026-06-08Labeling · Supplement 38 · standardAP
2026-06-08Labeling · Supplement 34 · standardAP
2014-12-21Labeling · Supplement 28 · standardAP
2009-07-09Labeling · Supplement 23AP
2005-10-06Labeling · Supplement 14AP
2005-01-26Supplement · Supplement 9AP
2005-01-26Labeling · Supplement 8AP
2005-01-26Supplement · Supplement 6AP
2005-01-21Labeling · Supplement 13AP
2005-01-06Labeling · Supplement 11AP
2002-12-23Manufacturing (CMC) · Supplement 3AP
2002-12-23Manufacturing (CMC) · Supplement 4AP
2001-10-25Labeling · Supplement 2AP
2000-11-20Manufacturing (CMC) · Supplement 1AP
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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