← FDA DRUG APPROVALS

FDA ANDA · ANDA072696

NORTREL 28 DAY

norethindrone and ethinyl estradiol

Sponsor: BARR LABS

APPLICATION
ANDA072696
TYPE
ANDA
ORIGINAL APPROVAL
1992-02-28
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

NORTREL 1/35-28Prescription
ETHINYL ESTRADIOL 0.035MG, NORETHINDRONE 1MG · TABLET · ORAL-28

Approval history

2022-04-29Labeling · Supplement 33 · standardAP
2022-02-10Labeling · Supplement 28 · standardAP
2022-02-10Labeling · Supplement 27 · standardAP
2022-02-10Labeling · Supplement 25 · standardAP
2013-02-27Labeling · Supplement 23 · standardAP
2002-12-11Manufacturing (CMC) · Supplement 9AP
2001-12-04Manufacturing (CMC) · Supplement 12AP
2001-12-04Manufacturing (CMC) · Supplement 10AP
2001-08-07Manufacturing (CMC) · Supplement 8AP
2001-03-13Labeling · Supplement 7AP
2001-03-07Manufacturing (CMC) · Supplement 4AP
2001-03-07Manufacturing (CMC) · Supplement 2AP
2001-03-07Labeling · Supplement 5AP
2001-03-07Manufacturing (CMC) · Supplement 3AP
2001-03-07Manufacturing (CMC) · Supplement 1AP
1999-12-21Manufacturing (CMC) · Supplement 6AP
1992-02-28OriginalAP
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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