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FDA ANDA · ANDA213418

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Sponsor: GLENMARK PHARMS LTD

APPLICATION
ANDA213418
TYPE
ANDA
ORIGINAL APPROVAL
2022-07-27
LATEST ACTION
2024-01-09
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEPrescription
ETHINYL ESTRADIOL 0.02MG, NORETHINDRONE ACETATE 1MG · CAPSULE · ORAL

Approval history

2024-01-09Labeling · Supplement 4 · standardAP
2022-07-27UNKNOWN · Original · standardAP
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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