APPLICATION
NDA016725
TYPE
NDA
ORIGINAL APPROVAL
1968-11-08
LATEST ACTION
1986-07-11
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NORINYL 1+80 28-DAYDiscontinued
MESTRANOL 0.08MG, NORETHINDRONE 1MG · TABLET · ORAL-28
Approval history
1986-07-11Labeling · Supplement 108AP
1985-10-25Labeling · Supplement 107AP
1985-04-16Labeling · Supplement 106AP
1984-11-13Manufacturing (CMC) · Supplement 104 · standardAP
1984-09-27Manufacturing (CMC) · Supplement 103 · standardAP
1984-07-30Labeling · Supplement 102AP
1984-06-12Labeling · Supplement 101AP
1984-05-07Labeling · Supplement 99AP
1984-03-06Labeling · Supplement 95AP
1983-07-26Manufacturing (CMC) · Supplement 98 · standardAP
1983-07-26Manufacturing (CMC) · Supplement 94 · standardAP
1983-07-19Manufacturing (CMC) · Supplement 97 · standardAP
1983-07-19Manufacturing (CMC) · Supplement 96 · standardAP
1983-06-13Manufacturing (CMC) · Supplement 93 · standardAP
1982-07-29Manufacturing (CMC) · Supplement 89 · standardAP
1982-01-11Manufacturing (CMC) · Supplement 85 · standardAP
1980-10-14Labeling · Supplement 47AP
1980-04-20Manufacturing (CMC) · Supplement 79 · standardAP
1979-07-18Manufacturing (CMC) · Supplement 75 · standardAP
1979-07-18Manufacturing (CMC) · Supplement 78 · standardAP
1978-11-06Manufacturing (CMC) · Supplement 70 · standardAP
1978-11-06Manufacturing (CMC) · Supplement 69 · standardAP
1978-05-26Manufacturing (CMC) · Supplement 68 · standardAP
1977-11-22Labeling · Supplement 58AP
1977-07-01Labeling · Supplement 48AP
1977-07-01Labeling · Supplement 49AP
1977-06-14Labeling · Supplement 56AP
1977-06-14Labeling · Supplement 54AP
1977-06-14Labeling · Supplement 55AP
1977-06-14Labeling · Supplement 53AP
1975-05-16Labeling · Supplement 42AP
1975-05-16Manufacturing (CMC) · Supplement 34 · standardAP
1975-05-16Manufacturing (CMC) · Supplement 40 · standardAP
1975-05-16Manufacturing (CMC) · Supplement 37 · standardAP
1975-05-16Manufacturing (CMC) · Supplement 29 · standardAP
1975-05-16Labeling · Supplement 31AP
1968-11-08Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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