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FDA ANDA · ANDA207054

NYLIA 7/7/7

norethindrone and ethinyl estradiol

Sponsor: AUROBINDO PHARMA

APPLICATION
ANDA207054
TYPE
ANDA
ORIGINAL APPROVAL
2016-10-21
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

NYLIA 7/7/7Prescription
ETHINYL ESTRADIOL 0.035MG,0.035MG,0.035MG, NORETHINDRONE 0.5MG,0.75MG,1MG · TABLET · ORAL-28

Approval history

2022-04-29Labeling · Supplement 3 · standardAP
2020-06-11Labeling · Supplement 1 · standardAP
2016-10-21UNKNOWN · 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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