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FDA ANDA · ANDA202742

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Sponsor: XIROMED

APPLICATION
ANDA202742
TYPE
ANDA
ORIGINAL APPROVAL
2014-10-30
LATEST ACTION
2024-04-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEDiscontinued
ETHINYL ESTRADIOL 0.02MG, NORETHINDRONE ACETATE 1MG · TABLET · ORAL

Approval history

2024-04-30Labeling · Supplement 12 · standardAP
2024-04-30Labeling · Supplement 10 · standardAP
2022-04-29Labeling · Supplement 9 · standardAP
2022-01-28Labeling · Supplement 8 · standardAP
2018-11-08Labeling · Supplement 4 · standardAP
2018-11-08Labeling · Supplement 3 · standardAP
2018-11-08Labeling · Supplement 1 · standardAP
2014-10-30UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

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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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