APPLICATION
ANDA212313
TYPE
ANDA
ORIGINAL APPROVAL
2021-07-15
LATEST ACTION
2025-05-19
ROUTE
VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
ESTRADIOLPrescription
ESTRADIOL 0.01% · CREAM · VAGINAL
Approval history
2025-05-19Labeling · Supplement 3 · standardAP
2024-02-16Labeling · Supplement 2 · standardAP
2024-02-08Labeling · Supplement 1 · standardAP
2021-07-15UNKNOWN · 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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