← FDA DRUG APPROVALS

FDA ANDA · ANDA076064

JUNEL FE 28 DAY

norethindrone acetate and ethinyl estradiol and ferrous fumarate

Sponsor: BARR

APPLICATION
ANDA076064
TYPE
ANDA
ORIGINAL APPROVAL
2003-09-18
LATEST ACTION
2023-09-25
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

JUNEL FE 1.5/30Prescription
ETHINYL ESTRADIOL 0.03MG, NORETHINDRONE ACETATE 1.5MG · TABLET · ORAL-28

Approval history

2023-09-25Labeling · Supplement 26 · standardAP
2023-09-25Labeling · Supplement 30 · standardAP
2021-08-18Labeling · Supplement 18 · standardAP
2004-10-20Labeling · Supplement 3AP
2003-09-18OriginalAP
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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