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FDA ANDA · ANDA204213

FYAVOLV

norethindrone acetate and ethinyl estradiol

Sponsor: LUPIN

APPLICATION
ANDA204213
TYPE
ANDA
ORIGINAL APPROVAL
2015-12-10
LATEST ACTION
2024-02-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

FYAVOLVPrescription
ETHINYL ESTRADIOL 0.0025MG, NORETHINDRONE ACETATE 0.5MG · TABLET · ORAL
FYAVOLVPrescription
ETHINYL ESTRADIOL 0.005MG, NORETHINDRONE ACETATE 1MG · TABLET · ORAL

Approval history

2024-02-16Labeling · Supplement 8 · standardAP
2021-05-06Manufacturing (CMC) · Supplement 6AP
2015-12-10UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

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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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