APPLICATION
NDA017060
TYPE
NDA
ORIGINAL APPROVAL
1973-01-02
LATEST ACTION
2015-12-03
ROUTE
ORAL, ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NOR-QD · ReferencePrescription
NORETHINDRONE 0.35MG · TABLET · ORAL-28
Approval history
2015-12-03Manufacturing (CMC) · Supplement 83 · standardAP
2015-10-09Manufacturing (CMC) · Supplement 82 · standardAP
2012-12-17Manufacturing (CMC) · Supplement 81 · standardAP
1999-11-30Labeling · Supplement 64 · standardAP
1999-09-30Manufacturing (CMC) · Supplement 66 · standardAP
1999-02-24Manufacturing (CMC) · Supplement 65 · standardAP
1996-12-11Labeling · Supplement 63 · standardAP
1995-05-26Labeling · Supplement 61 · standardAP
1995-05-23Labeling · Supplement 62 · standardAP
1990-11-02Labeling · Supplement 58AP
1990-09-19Manufacturing (CMC) · Supplement 59 · standardAP
1986-10-22Labeling · Supplement 56AP
1985-10-25Labeling · Supplement 55AP
1985-06-19Labeling · Supplement 54AP
1984-11-13Manufacturing (CMC) · Supplement 52 · standardAP
1984-09-27Manufacturing (CMC) · Supplement 50 · standardAP
1984-06-12Labeling · Supplement 51AP
1984-03-28Labeling · Supplement 46AP
1983-07-26Manufacturing (CMC) · Supplement 49 · standardAP
1983-07-26Manufacturing (CMC) · Supplement 45 · standardAP
1983-07-19Manufacturing (CMC) · Supplement 47 · standardAP
1983-07-19Manufacturing (CMC) · Supplement 48 · standardAP
1983-06-13Manufacturing (CMC) · Supplement 44 · standardAP
1982-07-29Manufacturing (CMC) · Supplement 41 · standardAP
1981-01-02Labeling · Supplement 16AP
1980-05-20Manufacturing (CMC) · Supplement 37 · standardAP
1979-07-18Manufacturing (CMC) · Supplement 33 · standardAP
1979-07-18Manufacturing (CMC) · Supplement 36 · standardAP
1978-11-06Manufacturing (CMC) · Supplement 29 · standardAP
1978-11-06Manufacturing (CMC) · Supplement 28 · standardAP
1978-05-26Manufacturing (CMC) · Supplement 27 · standardAP
1977-07-01Labeling · Supplement 17AP
1977-07-01Labeling · Supplement 18AP
1976-06-25Manufacturing (CMC) · Supplement 13 · standardAP
1975-05-16Labeling · Supplement 10AP
1975-05-16Manufacturing (CMC) · Supplement 8 · standardAP
1975-05-16Manufacturing (CMC) · Supplement 6 · standardAP
1973-01-02Type 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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