APPLICATION
NDA016029
TYPE
NDA
ORIGINAL APPROVAL
1966-03-23
LATEST ACTION
1986-10-23
ROUTE
ORAL-21, ORAL-20
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
OVULEN-21Discontinued
ETHYNODIOL DIACETATE 1MG, MESTRANOL 0.1MG · TABLET · ORAL-21
OVULENDiscontinued
ETHYNODIOL DIACETATE 1MG, MESTRANOL 0.1MG · TABLET · ORAL-20
Approval history
1986-10-23Labeling · Supplement 65AP
1986-06-10Labeling · Supplement 64AP
1986-03-13Labeling · Supplement 63AP
1985-06-05Labeling · Supplement 62AP
1985-04-05Labeling · Supplement 61AP
1985-02-12Labeling · Supplement 60AP
1984-09-18Labeling · Supplement 59AP
1984-03-06Labeling · Supplement 57AP
1983-06-09Manufacturing (CMC) · Supplement 54 · standardAP
1983-06-03Manufacturing (CMC) · Supplement 55 · standardAP
1982-11-22Manufacturing (CMC) · Supplement 52 · standardAP
1981-03-03Labeling · Supplement 35AP
1979-05-16Manufacturing (CMC) · Supplement 49 · standardAP
1966-03-23Type 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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