APPLICATION
NDA016659
TYPE
NDA
ORIGINAL APPROVAL
1967-11-17
LATEST ACTION
2013-12-03
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NORINYL 1+50 28-DAY · ReferenceDiscontinued
MESTRANOL 0.05MG, NORETHINDRONE 1MG · TABLET · ORAL-28
Approval history
2013-12-03Manufacturing (CMC) · Supplement 136 · priorityAP
2013-10-30Manufacturing (CMC) · Supplement 137 · priorityAP
2000-01-24Labeling · Supplement 125 · standardAP
1999-05-14Manufacturing (CMC) · Supplement 124 · priorityAP
1999-02-04Manufacturing (CMC) · Supplement 123 · priorityAP
1997-07-30Manufacturing (CMC) · Supplement 122 · priorityAP
1995-08-30Labeling · Supplement 120 · standardAP
1994-12-13Labeling · Supplement 121 · standardAP
1994-02-04Labeling · Supplement 118AP
1992-07-31Manufacturing (CMC) · Supplement 119 · priorityAP
1991-10-09Manufacturing (CMC) · Supplement 117 · priorityAP
1990-11-02Labeling · Supplement 113AP
1990-09-19Manufacturing (CMC) · Supplement 116 · priorityAP
1990-08-15Manufacturing (CMC) · Supplement 115 · priorityAP
1986-07-17Labeling · Supplement 110AP
1985-10-25Labeling · Supplement 109AP
1985-04-16Labeling · Supplement 108AP
1984-11-13Manufacturing (CMC) · Supplement 106 · priorityAP
1984-09-27Manufacturing (CMC) · Supplement 102 · priorityAP
1984-07-30Labeling · Supplement 105AP
1984-06-12Labeling · Supplement 104AP
1984-05-07Labeling · Supplement 101AP
1984-03-06Labeling · Supplement 97AP
1983-07-26Manufacturing (CMC) · Supplement 96 · priorityAP
1983-07-26Manufacturing (CMC) · Supplement 100 · priorityAP
1983-07-19Manufacturing (CMC) · Supplement 99 · priorityAP
1983-07-19Manufacturing (CMC) · Supplement 98 · priorityAP
1983-06-13Manufacturing (CMC) · Supplement 95 · priorityAP
1982-09-07Manufacturing (CMC) · Supplement 89 · priorityAP
1982-07-29Manufacturing (CMC) · Supplement 92 · priorityAP
1982-01-11Manufacturing (CMC) · Supplement 87 · priorityAP
1980-10-14Labeling · Supplement 53AP
1979-07-18Manufacturing (CMC) · Supplement 82 · priorityAP
1979-07-18Manufacturing (CMC) · Supplement 79 · priorityAP
1978-11-06Manufacturing (CMC) · Supplement 74 · priorityAP
1978-11-06Manufacturing (CMC) · Supplement 75 · priorityAP
1978-05-26Manufacturing (CMC) · Supplement 73 · priorityAP
1977-07-01Labeling · Supplement 54AP
1977-07-01Labeling · Supplement 55AP
1977-06-14Labeling · Supplement 60AP
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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