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FDA ANDA · ANDA091105
ELINEST
norgestrel and ethinyl estradiol
Sponsor: NOVAST LABS LTD
APPLICATION
ANDA091105
TYPE
ANDA
ORIGINAL APPROVAL
2012-03-28
LATEST ACTION
2026-07-10
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ELINESTPrescription
ETHINYL ESTRADIOL 0.03MG, NORGESTREL 0.3MG · TABLET · ORAL-28
Approval history
2026-07-10Labeling · Supplement 6 · standardAP
2017-08-09Labeling · Supplement 2 · standardAP
2012-03-28OriginalAP
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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