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FDA ANDA · ANDA207581
AUROVELA 1.5/30
norethindrone acetate and ethinyl estradiol
Sponsor: AUROBINDO PHARMA
APPLICATION
ANDA207581
TYPE
ANDA
ORIGINAL APPROVAL
2017-06-26
LATEST ACTION
2024-02-01
ROUTE
ORAL, ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AUROVELA 1.5/30Prescription
ETHINYL ESTRADIOL 0.03MG, NORETHINDRONE ACETATE 1.5MG · TABLET · ORAL-21
Approval history
2024-02-01Labeling · Supplement 9 · standardAP
2024-02-01Labeling · Supplement 7 · standardAP
2024-02-01Labeling · Supplement 1 · standardAP
2017-06-26UNKNOWN · 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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