APPLICATION
ANDA076783
TYPE
ANDA
ORIGINAL APPROVAL
2004-09-29
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ARANELLEPrescription
ETHINYL ESTRADIOL 0.035MG,0.035MG,0.035MG, NORETHINDRONE 0.5MG,1MG,0.5MG · TABLET · ORAL-28
Approval history
2022-04-29Labeling · Supplement 16 · standardAP
2020-07-06Labeling · Supplement 11 · standardAP
2004-09-29OriginalAP
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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