APPLICATION
ANDA071539
TYPE
ANDA
ORIGINAL APPROVAL
1988-04-12
LATEST ACTION
2022-04-29
ROUTE
ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NORETHIN 1/50M-21Discontinued
MESTRANOL 0.05MG, NORETHINDRONE 1MG · TABLET · ORAL-21
Approval history
2022-04-29Labeling · Supplement 10 · standardAP
1997-07-11Labeling · Supplement 9AP
1993-12-23Manufacturing (CMC) · Supplement 8AP
1992-08-28Labeling · Supplement 7AP
1991-10-11Labeling · Supplement 6AP
1991-09-09Manufacturing (CMC) · Supplement 5AP
1991-06-19Manufacturing (CMC) · Supplement 3AP
1991-05-28Labeling · Supplement 4AP
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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