← FDA DRUG APPROVALS
FDA ANDA · ANDA206287
MIBELAS 24 FE
norethindrone acetate, ethinyl estradiol and ferrous fumarate
Sponsor: LUPIN
APPLICATION
ANDA206287
TYPE
ANDA
ORIGINAL APPROVAL
2016-05-24
LATEST ACTION
2023-06-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MIBELAS 24 FEPrescription
ETHINYL ESTRADIOL 0.02MG, NORETHINDRONE ACETATE 1MG · TABLET · ORAL
Approval history
2023-06-22Labeling · Supplement 18 · standardAP
2019-09-09Manufacturing (CMC) · Supplement 8 · unknownAP
2019-09-09Labeling · Supplement 6 · standardAP
2019-09-09Labeling · Supplement 1 · 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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