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FDA ANDA · ANDA213317

GEMMILY

norethindrone acetate and ethinyl estradiol, and ferrous fumarate

Sponsor: XIROMED

APPLICATION
ANDA213317
TYPE
ANDA
ORIGINAL APPROVAL
2020-11-09
LATEST ACTION
2024-06-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

GEMMILYPrescription
ETHINYL ESTRADIOL 0.02MG, NORETHINDRONE ACETATE 1MG · CAPSULE · ORAL

Approval history

2024-06-13Labeling · Supplement 3 · standardAP
2024-06-13Labeling · Supplement 2 · standardAP
2020-11-09UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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