APPLICATION
NDA010976
TYPE
NDA
ORIGINAL APPROVAL
1961-03-09
LATEST ACTION
1986-10-23
ROUTE
ORAL, ORAL-20, ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ENOVIDDiscontinued
MESTRANOL 0.075MG, NORETHYNODREL 5MG · TABLET · ORAL
ENOVID-EDiscontinued
MESTRANOL 0.1MG, NORETHYNODREL 2.5MG · TABLET · ORAL-20
ENOVIDDiscontinued
MESTRANOL 0.075MG, NORETHYNODREL 5MG · TABLET · ORAL-20
ENOVID-E 21Discontinued
MESTRANOL 0.1MG, NORETHYNODREL 2.5MG · TABLET · ORAL-21
ENOVIDDiscontinued
MESTRANOL 0.15MG, NORETHYNODREL 9.85MG · TABLET · ORAL
Approval history
1986-10-23Labeling · Supplement 73AP
1986-06-10Labeling · Supplement 72AP
1986-03-13Labeling · Supplement 71AP
1985-06-05Labeling · Supplement 70AP
1985-04-05Labeling · Supplement 69AP
1984-09-18Labeling · Supplement 68AP
1984-03-06Labeling · Supplement 66AP
1983-06-23Manufacturing (CMC) · Supplement 63 · standardAP
1983-06-03Manufacturing (CMC) · Supplement 64 · standardAP
1982-11-22Manufacturing (CMC) · Supplement 61 · standardAP
1981-02-12Labeling · Supplement 42AP
1978-02-22Manufacturing (CMC) · Supplement 53 · standardAP
1961-03-09Type 1 - New Molecular Entity and Type 4 - New Combination · 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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