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FDA ANDA · ANDA091453
LARIN FE 1.5/30
norethindrone acetate/ethinyl estradiol and ferrous fumarate
Sponsor: NOVAST LABS
APPLICATION
ANDA091453
TYPE
ANDA
ORIGINAL APPROVAL
2013-08-23
LATEST ACTION
2023-07-17
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LARIN FE 1.5/30Prescription
ETHINYL ESTRADIOL 0.03MG, NORETHINDRONE ACETATE 1.5MG · TABLET · ORAL-28
Approval history
2023-07-17Labeling · Supplement 8 · standardAP
2023-07-17Labeling · Supplement 9 · standardAP
2020-07-31Labeling · Supplement 1 · standardAP
2013-08-23OriginalAP
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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