APPLICATION
NDA017566
TYPE
NDA
ORIGINAL APPROVAL
1974-12-26
LATEST ACTION
2017-10-10
ROUTE
ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
BREVICON 21-DAYDiscontinued
ETHINYL ESTRADIOL 0.035MG, NORETHINDRONE 0.5MG · TABLET · ORAL-21
Approval history
2001-08-15Manufacturing (CMC) · Supplement 85 · standardAP
2000-02-14Manufacturing (CMC) · Supplement 83 · standardAP
2000-01-24Labeling · Supplement 84 · standardAP
1997-07-30Manufacturing (CMC) · Supplement 82 · standardAP
1995-08-30Labeling · Supplement 79 · standardAP
1994-12-13Labeling · Supplement 80 · standardAP
1994-12-13Labeling · Supplement 81 · standardAP
1994-02-04Labeling · Supplement 77AP
1992-07-31Manufacturing (CMC) · Supplement 78 · standardAP
1990-11-02Labeling · Supplement 73AP
1990-09-19Manufacturing (CMC) · Supplement 76 · standardAP
1989-10-23Manufacturing (CMC) · Supplement 75 · standardAP
1989-02-22Manufacturing (CMC) · Supplement 74 · standardAP
1987-10-26Manufacturing (CMC) · Supplement 56 · standardAP
1986-07-17Labeling · Supplement 71AP
1985-10-25Labeling · Supplement 70AP
1985-04-16Labeling · Supplement 69AP
1984-11-13Manufacturing (CMC) · Supplement 67 · standardAP
1984-09-27Manufacturing (CMC) · Supplement 64 · standardAP
1984-07-30Labeling · Supplement 66AP
1984-05-16Manufacturing (CMC) · Supplement 55 · standardAP
1984-05-07Labeling · Supplement 63AP
1984-03-06Labeling · Supplement 59AP
1983-07-26Manufacturing (CMC) · Supplement 58 · standardAP
1983-07-26Manufacturing (CMC) · Supplement 62 · standardAP
1983-07-19Manufacturing (CMC) · Supplement 60 · standardAP
1983-07-19Manufacturing (CMC) · Supplement 61 · standardAP
1983-06-13Manufacturing (CMC) · Supplement 57 · standardAP
1982-07-29Manufacturing (CMC) · Supplement 52 · standardAP
1982-01-11Manufacturing (CMC) · Supplement 49 · standardAP
1980-12-18Manufacturing (CMC) · Supplement 44 · standardAP
1980-12-18Manufacturing (CMC) · Supplement 45 · standardAP
1980-10-14Labeling · Supplement 14AP
1980-07-31Manufacturing (CMC) · Supplement 42 · standardAP
1979-07-18Manufacturing (CMC) · Supplement 41 · standardAP
1979-07-18Manufacturing (CMC) · Supplement 38 · standardAP
1978-11-06Manufacturing (CMC) · Supplement 33 · standardAP
1978-11-06Manufacturing (CMC) · Supplement 34 · 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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