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FDA ANDA · ANDA205069
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
Sponsor: XIROMED
APPLICATION
ANDA205069
TYPE
ANDA
ORIGINAL APPROVAL
2018-06-22
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLPrescription
ETHINYL ESTRADIOL 0.02MG,0.03MG,0.035MG, NORETHINDRONE ACETATE 1MG,1MG,1MG · TABLET · ORAL-28
Approval history
2022-04-29Labeling · Supplement 3 · standardAP
2022-03-18Labeling · Supplement 2 · standardAP
2018-06-22UNKNOWN · Original · 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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