APPLICATION
ANDA205256
TYPE
ANDA
ORIGINAL APPROVAL
2015-05-29
LATEST ACTION
2025-08-04
ROUTE
VAGINAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ESTRADIOLPrescription
ESTRADIOL 10MCG · TABLET · VAGINAL
Approval history
2025-08-04Labeling · Supplement 12 · standardAP
2025-08-04Labeling · Supplement 10 · standardAP
2025-08-04Labeling · Supplement 11 · standardAP
2021-02-17Labeling · Supplement 2 · standardAP
2021-02-17Labeling · Supplement 3 · standardAP
2015-05-29UNKNOWN · 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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