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FDA ANDA · ANDA207261
ABIGALE LO
estradiol and norethindrone acetate
Sponsor: XIROMED
APPLICATION
ANDA207261
TYPE
ANDA
ORIGINAL APPROVAL
2017-02-10
LATEST ACTION
2025-06-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ESTRADIOL AND NORETHINDRONE ACETATEPrescription
ESTRADIOL 1MG, NORETHINDRONE ACETATE 0.5MG · TABLET · ORAL
ESTRADIOL AND NORETHINDRONE ACETATEPrescription
ESTRADIOL 0.5MG, NORETHINDRONE ACETATE 0.1MG · TABLET · ORAL
Approval history
2025-06-20Labeling · Supplement 3 · standardAP
2025-06-20Labeling · Supplement 1 · standardAP
2025-06-20Labeling · Supplement 6 · standardAP
2025-06-20Labeling · Supplement 2 · standardAP
2017-02-10UNKNOWN · 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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