APPLICATION
ANDA040275
TYPE
ANDA
ORIGINAL APPROVAL
1998-12-29
LATEST ACTION
2026-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ESTRADIOLPrescription
ESTRADIOL 1MG · TABLET · ORAL
ESTRADIOLPrescription
ESTRADIOL 2MG · TABLET · ORAL
ESTRADIOLPrescription
ESTRADIOL 0.5MG · TABLET · ORAL
Approval history
2026-01-22Labeling · Supplement 14 · standardAP
2024-02-16Labeling · Supplement 13 · standardAP
2019-01-04Labeling · Supplement 10 · standardAP
1999-11-01Labeling · Supplement 2AP
1999-11-01Manufacturing (CMC) · Supplement 1AP
1999-09-24Labeling · Supplement 3AP
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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