APPLICATION
ANDA071540
TYPE
ANDA
ORIGINAL APPROVAL
1988-04-12
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NORETHIN 1/50M-28Discontinued
MESTRANOL 0.05MG, NORETHINDRONE 1MG · TABLET · ORAL-28
Approval history
2022-04-29Labeling · Supplement 14 · standardAP
1997-07-11Labeling · Supplement 13AP
1997-01-13Manufacturing (CMC) · Supplement 11AP
1997-01-13Manufacturing (CMC) · Supplement 12AP
1993-12-23Manufacturing (CMC) · Supplement 10AP
1992-08-28Labeling · Supplement 8AP
1992-05-01Labeling · Supplement 9AP
1991-10-11Labeling · Supplement 7AP
1991-09-09Manufacturing (CMC) · Supplement 6AP
1991-06-19Manufacturing (CMC) · Supplement 4AP
1991-05-28Labeling · Supplement 5AP
1991-03-22Manufacturing (CMC) · Supplement 2AP
1988-04-12OriginalAP
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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