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FDA ANDA · ANDA078267
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
Sponsor: AMNEAL PHARMS
APPLICATION
ANDA078267
TYPE
ANDA
ORIGINAL APPROVAL
2009-09-01
LATEST ACTION
2024-02-23
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
2024-02-23Labeling · Supplement 16 · standardAP
2022-04-29Labeling · Supplement 15 · standardAP
2022-02-07Labeling · Supplement 14 · standardAP
2019-09-09Labeling · Supplement 9 · 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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