APPLICATION
NDA016705
TYPE
NDA
ORIGINAL APPROVAL
1967-10-02
LATEST ACTION
1986-10-23
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
OVULEN-28Discontinued
ETHYNODIOL DIACETATE 1MG, MESTRANOL 0.1MG · TABLET · ORAL-28
Approval history
1986-10-23Labeling · Supplement 42AP
1986-06-10Labeling · Supplement 41AP
1986-03-13Labeling · Supplement 40AP
1985-06-05Labeling · Supplement 39AP
1985-04-05Labeling · Supplement 38AP
1985-02-12Labeling · Supplement 37AP
1984-09-18Labeling · Supplement 36AP
1984-03-06Labeling · Supplement 34AP
1981-03-05Labeling · Supplement 20AP
1967-10-02Type 3 - New Dosage Form · 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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