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FDA ANDA · ANDA207056
NYLIA 1/35
norethindrone and ethinyl estradiol
Sponsor: AUROBINDO PHARMA
APPLICATION
ANDA207056
TYPE
ANDA
ORIGINAL APPROVAL
2016-10-21
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NYLIA 1/35Prescription
ETHINYL ESTRADIOL 0.035MG, NORETHINDRONE 1MG · TABLET · ORAL-28
Approval history
2022-04-29Labeling · Supplement 3 · standardAP
2022-02-10Labeling · Supplement 1 · standardAP
2016-10-21UNKNOWN · 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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