APPLICATION
NDA016724
TYPE
NDA
ORIGINAL APPROVAL
1968-11-06
LATEST ACTION
1986-07-17
ROUTE
ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NORINYL 1+80 21-DAYDiscontinued
MESTRANOL 0.08MG, NORETHINDRONE 1MG · TABLET · ORAL-21
Approval history
1986-07-17Labeling · Supplement 108AP
1985-10-25Labeling · Supplement 107AP
1985-04-16Labeling · Supplement 106AP
1984-11-13Manufacturing (CMC) · Supplement 104 · standardAP
1984-09-27Manufacturing (CMC) · Supplement 101 · standardAP
1984-07-30Labeling · Supplement 103AP
1984-05-07Labeling · Supplement 100AP
1984-03-06Labeling · Supplement 96AP
1983-07-26Manufacturing (CMC) · Supplement 99 · standardAP
1983-07-26Manufacturing (CMC) · Supplement 95 · standardAP
1983-07-19Manufacturing (CMC) · Supplement 98 · standardAP
1983-07-19Manufacturing (CMC) · Supplement 97 · standardAP
1983-06-13Manufacturing (CMC) · Supplement 94 · standardAP
1982-07-29Manufacturing (CMC) · Supplement 90 · standardAP
1982-01-11Manufacturing (CMC) · Supplement 86 · standardAP
1980-10-14Labeling · Supplement 46AP
1980-04-17Manufacturing (CMC) · Supplement 81 · standardAP
1979-07-18Manufacturing (CMC) · Supplement 80 · standardAP
1979-07-18Manufacturing (CMC) · Supplement 77 · standardAP
1978-11-06Manufacturing (CMC) · Supplement 71 · standardAP
1978-11-06Manufacturing (CMC) · Supplement 68 · standardAP
1978-05-26Manufacturing (CMC) · Supplement 67 · standardAP
1977-11-22Labeling · Supplement 57AP
1977-11-22Labeling · Supplement 58AP
1977-07-01Labeling · Supplement 47AP
1977-07-01Labeling · Supplement 48AP
1977-06-14Labeling · Supplement 55AP
1977-06-14Labeling · Supplement 53AP
1977-06-14Labeling · Supplement 54AP
1977-06-14Labeling · Supplement 52AP
1976-09-29Manufacturing (CMC) · Supplement 45 · standardAP
1975-05-16Manufacturing (CMC) · Supplement 37 · standardAP
1975-05-16Labeling · Supplement 29AP
1975-05-16Manufacturing (CMC) · Supplement 33 · standardAP
1975-05-16Labeling · Supplement 42AP
1975-05-16Manufacturing (CMC) · Supplement 34 · standardAP
1975-05-16Manufacturing (CMC) · Supplement 40 · standardAP
1975-05-16Manufacturing (CMC) · Supplement 30 · standardAP
1968-11-06Type 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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