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FDA NDA · NDA022501

LO LOESTRIN FE

norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate

Sponsor: APIL

APPLICATION
NDA022501
TYPE
NDA
ORIGINAL APPROVAL
2010-10-21
LATEST ACTION
2022-04-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LO LOESTRIN FE · ReferencePrescription
ETHINYL ESTRADIOL 0.01MG,0.01MG, NORETHINDRONE ACETATE 1MG,N/A · TABLET · ORAL

Approval history

2022-04-29Labeling · Supplement 15 · standard — Letter ↗AP
2021-10-15Labeling · Supplement 12 · standard — Label ↗AP
2017-10-10Labeling · Supplement 9 · standard — Label ↗AP
2017-08-09Labeling · Supplement 8 · standard — Label ↗AP
2013-05-08Manufacturing (CMC) · Supplement 5 · standardAP
2013-03-01Manufacturing (CMC) · Supplement 4 · standardAP
2010-10-21Type 3 - New Dosage Form · Original · standard — Review ↗AP
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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