APPLICATION
ANDA203339
TYPE
ANDA
ORIGINAL APPROVAL
2016-06-20
LATEST ACTION
2023-03-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AMABELZPrescription
ESTRADIOL 1MG, NORETHINDRONE ACETATE 0.5MG · TABLET · ORAL
AMABELZPrescription
ESTRADIOL 0.5MG, NORETHINDRONE ACETATE 0.1MG · TABLET · ORAL
Approval history
2023-03-15Labeling · Supplement 13 · standardAP
2017-04-21Manufacturing (CMC) · Supplement 1 · unknownAP
2016-06-20UNKNOWN · OriginalAP
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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