← FDA DRUG APPROVALS
FDA ANDA · ANDA202772
FEIRZA 1/20
norethindrone acetate and ethinyl estradiol tablets usp, 1 mg/0.02 mg and ferrous fumarate tablets, 75 mg
Sponsor: XIROMED
APPLICATION
ANDA202772
TYPE
ANDA
ORIGINAL APPROVAL
2013-11-14
LATEST ACTION
2025-02-18
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLPrescription
ETHINYL ESTRADIOL 0.02MG, NORETHINDRONE ACETATE 1MG · TABLET · ORAL-28
Approval history
2025-02-18Labeling · Supplement 9 · standardAP
2025-02-18Labeling · Supplement 7 · standardAP
2018-11-08Labeling · Supplement 3 · standardAP
2018-11-08Labeling · Supplement 2 · standardAP
2013-11-14UNKNOWN · 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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