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FDA ANDA · ANDA072692

NORTREL 0.5/35-21

Sponsor: BARR

APPLICATION
ANDA072692
TYPE
ANDA
ORIGINAL APPROVAL
1992-02-28
LATEST ACTION
2002-12-11
ROUTE
ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

NORTREL 0.5/35-21Discontinued
ETHINYL ESTRADIOL 0.035MG, NORETHINDRONE 0.5MG · TABLET · ORAL-21

Approval history

2002-12-11Manufacturing (CMC) · Supplement 9AP
2001-12-04Manufacturing (CMC) · Supplement 12AP
2001-12-04Manufacturing (CMC) · Supplement 10AP
2001-08-22Manufacturing (CMC) · Supplement 8AP
2001-03-13Labeling · Supplement 7AP
2001-03-07Labeling · Supplement 5AP
2001-03-07Manufacturing (CMC) · Supplement 3AP
2001-03-07Manufacturing (CMC) · Supplement 1AP
2001-03-07Manufacturing (CMC) · Supplement 4AP
2001-03-07Manufacturing (CMC) · Supplement 2AP
1999-12-21Manufacturing (CMC) · Supplement 6AP
1992-02-28OriginalAP
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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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