APPLICATION
ANDA211293
TYPE
ANDA
ORIGINAL APPROVAL
2019-02-05
LATEST ACTION
2024-08-26
ROUTE
TRANSDERMAL
DOSAGE FORM
SYSTEM
MARKETING STATUS
Prescription
Products
ESTRADIOLPrescription
ESTRADIOL 0.025MG/24HR · SYSTEM · TRANSDERMAL
ESTRADIOLPrescription
ESTRADIOL 0.075MG/24HR · SYSTEM · TRANSDERMAL
ESTRADIOLPrescription
ESTRADIOL 0.0375MG/24HR · SYSTEM · TRANSDERMAL
ESTRADIOLPrescription
ESTRADIOL 0.1MG/24HR · SYSTEM · TRANSDERMAL
ESTRADIOLPrescription
ESTRADIOL 0.05MG/24HR · SYSTEM · TRANSDERMAL
Approval history
2024-08-26Labeling · Supplement 11 · standardAP
2023-11-16Labeling · Supplement 9 · standardAP
2019-02-05UNKNOWN · Original · standardAP
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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