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FDA ANDA · ANDA202086

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Sponsor: XIROMED

APPLICATION
ANDA202086
TYPE
ANDA
ORIGINAL APPROVAL
2015-04-01
LATEST ACTION
2022-04-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEPrescription
ETHINYL ESTRADIOL 0.035MG, NORETHINDRONE 0.4MG · TABLET · ORAL

Approval history

2022-04-29Labeling · Supplement 4 · standardAP
2022-01-28Labeling · Supplement 1 · standardAP
2022-01-28Labeling · Supplement 2 · standardAP
2015-04-01Not Applicable · OriginalAP
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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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