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FDA ANDA · ANDA207580

AUROVELA FE

norethindrone acetate and ethinyl estradiol and ferrous fumarate

Sponsor: AUROBINDO PHARMA

APPLICATION
ANDA207580
TYPE
ANDA
ORIGINAL APPROVAL
2017-06-15
LATEST ACTION
2023-10-30
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

AUROVELA FE 1.5/30Prescription
ETHINYL ESTRADIOL 0.03MG, NORETHINDRONE ACETATE 1.5MG · TABLET · ORAL-28

Approval history

2023-10-30Labeling · Supplement 9 · standardAP
2023-10-30Labeling · Supplement 7 · standardAP
2023-10-30Labeling · Supplement 1 · standardAP
2017-06-15UNKNOWN · Original · standardAP
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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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