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FDA ANDA · ANDA090938

JUNEL FE 24

norethindrone acetate and ethinyl estradiol and ferrous fumarate

Sponsor: BARR LABS

APPLICATION
ANDA090938
TYPE
ANDA
ORIGINAL APPROVAL
2014-12-01
LATEST ACTION
2022-04-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval), Prescription

Products

FERROUS FUMARATENone (Tentative Approval)
FERROUS FUMARATE 75MG · TABLET · ORAL
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEPrescription
ETHINYL ESTRADIOL 0.02MG, NORETHINDRONE ACETATE 1MG · TABLET · ORAL

Approval history

2022-04-29Labeling · Supplement 12 · standardAP
2022-02-16Labeling · Supplement 11 · standardAP
2022-02-16Labeling · Supplement 3 · standardAP
2022-02-16Labeling · Supplement 2 · standardAP
2014-12-01OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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