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FDA ANDA · ANDA203448

KAITLIB FE

norethindrone and ethinyl estradiol

Sponsor: LUPIN

APPLICATION
ANDA203448
TYPE
ANDA
ORIGINAL APPROVAL
2015-12-17
LATEST ACTION
2024-05-06
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Prescription

Products

KAITLIB FEPrescription
ETHINYL ESTRADIOL 0.025MG, NORETHINDRONE 0.8MG · TABLET, CHEWABLE · ORAL

Approval history

2024-05-06Manufacturing (CMC) · Supplement 5 · unknownAP
2024-05-06Labeling · Supplement 3 · standardAP
2015-12-17UNKNOWN · OriginalAP
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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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