← FDA DRUG APPROVALS

FDA ANDA · ANDA075478

NORTREL 7/7/7 (28 DAY REGIMEN)

norethindrone and ethinyl estradiol

Sponsor: BARR

APPLICATION
ANDA075478
TYPE
ANDA
ORIGINAL APPROVAL
2002-08-30
LATEST ACTION
2022-04-29
ROUTE
ORAL-28, ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

NORTREL 7/7/7Prescription
ETHINYL ESTRADIOL 0.035MG,0.035MG,0.035MG, NORETHINDRONE 0.5MG,0.75MG,1MG · TABLET · ORAL-28
NORTREL 7/7/7Prescription
ETHINYL ESTRADIOL 0.035MG,0.035MG,0.035MG, NORETHINDRONE 0.5MG,0.75MG,1MG · TABLET · ORAL-21

Approval history

2022-04-29Labeling · Supplement 22 · standardAP
2020-07-06Labeling · Supplement 18 · standardAP
2016-08-26Labeling · Supplement 17 · standardAP
2015-01-20Labeling · Supplement 15 · standardAP
2014-12-31Labeling · Supplement 13 · standardAP
2004-04-20Labeling · Supplement 3AP
2002-08-30Original — 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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