← FDA DRUG APPROVALS

FDA ANDA · ANDA214292

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE

Sponsor: AMNEAL PHARMS

APPLICATION
ANDA214292
TYPE
ANDA
ORIGINAL APPROVAL
2021-07-20
LATEST ACTION
2023-09-28
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

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

Approval history

2023-09-28Labeling · Supplement 5 · standardAP
2023-09-28Labeling · Supplement 12 · standardAP
2021-07-20UNKNOWN · 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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