APPLICATION
ANDA070758
TYPE
ANDA
ORIGINAL APPROVAL
1988-07-01
LATEST ACTION
2022-04-29
ROUTE
ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NORETHINDRONE AND MESTRANOLDiscontinued
MESTRANOL 0.05MG, NORETHINDRONE 1MG · TABLET · ORAL-21
Approval history
2022-04-29Labeling · Supplement 17 · standardAP
2002-06-26Manufacturing (CMC) · Supplement 10AP
2002-05-21Manufacturing (CMC) · Supplement 9AP
2002-05-08Labeling · Supplement 6AP
2001-01-29Manufacturing (CMC) · Supplement 7AP
1997-05-01Labeling · Supplement 5AP
1993-11-04Labeling · Supplement 4AP
1993-08-10Manufacturing (CMC) · Supplement 3AP
1990-03-15Labeling · Supplement 2AP
1989-07-31Labeling · Supplement 1AP
1988-07-01OriginalAP
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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