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FDA ANDA · ANDA078965
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
Sponsor: BARR
APPLICATION
ANDA078965
TYPE
ANDA
ORIGINAL APPROVAL
2010-08-05
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 8 · standardAP
2022-01-28Labeling · Supplement 6 · 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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