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FDA ANDA · ANDA202962

TILIA FE

ndac and ee tablets and ferrous fumarate tablets

Sponsor: NOVAST LABS

APPLICATION
ANDA202962
TYPE
ANDA
ORIGINAL APPROVAL
2020-04-15
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

CHABELINA FEPrescription
ETHINYL ESTRADIOL 0.02MG,0.03MG,0.035MG, NORETHINDRONE ACETATE 1MG,1MG,1MG · TABLET · ORAL-28

Approval history

2022-04-29Labeling · Supplement 6 · standardAP
2022-03-18Labeling · Supplement 4 · standardAP
2020-04-15UNKNOWN · 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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