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FDA ANDA · ANDA090947
PHILITH
norethindrone and ethinyl estradiol tablets
Sponsor: NOVAST LABS LTD
APPLICATION
ANDA090947
TYPE
ANDA
ORIGINAL APPROVAL
2011-12-22
LATEST ACTION
2022-04-29
ROUTE
ORAL, ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PHILITHPrescription
ETHINYL ESTRADIOL 0.035MG, NORETHINDRONE 0.4MG · TABLET · ORAL-28
Approval history
2022-04-29Labeling · Supplement 5 · standardAP
2017-08-09Labeling · Supplement 2 · standardAP
2011-12-22OriginalAP
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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