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FDA ANDA · ANDA202770

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

Sponsor: XIROMED

APPLICATION
ANDA202770
TYPE
ANDA
ORIGINAL APPROVAL
2015-02-19
LATEST ACTION
2024-04-24
ROUTE
ORAL, ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLPrescription
ETHINYL ESTRADIOL 0.03MG, NORETHINDRONE ACETATE 1.5MG · TABLET · ORAL-21

Approval history

2024-04-24Labeling · Supplement 9 · standardAP
2024-04-24Labeling · Supplement 7 · standardAP
2018-11-08Labeling · Supplement 3 · standardAP
2018-11-08Labeling · Supplement 2 · standardAP
2015-02-19UNKNOWN · 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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