APPLICATION
NDA017247
TYPE
NDA
ORIGINAL APPROVAL
1973-06-14
LATEST ACTION
2001-09-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SANOREX · ReferenceDiscontinued
MAZINDOL 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
SANOREX · ReferenceDiscontinued
MAZINDOL 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2001-09-17Manufacturing (CMC) · Supplement 42 · standardAP
1996-02-27Manufacturing (CMC) · Supplement 41 · standardAP
1995-10-17Manufacturing (CMC) · Supplement 40 · standardAP
1995-03-13Manufacturing (CMC) · Supplement 37 · standardAP
1994-09-19Manufacturing (CMC) · Supplement 38 · standardAP
1994-03-29Manufacturing (CMC) · Supplement 33 · standardAP
1992-11-27Labeling · Supplement 36 · standardAP
1991-08-02Manufacturing (CMC) · Supplement 34 · standardAP
1990-03-14Manufacturing (CMC) · Supplement 32 · standardAP
1989-09-14Manufacturing (CMC) · Supplement 31 · standardAP
1986-11-18Labeling · Supplement 29AP
1982-01-06Labeling · Supplement 25AP
1981-06-25Manufacturing (CMC) · Supplement 27 · standardAP
1981-01-21Manufacturing (CMC) · Supplement 26 · standardAP
1979-09-19Manufacturing (CMC) · Supplement 21 · standardAP
1979-03-23Manufacturing (CMC) · Supplement 23 · standardAP
1979-01-16Manufacturing (CMC) · Supplement 24 · standardAP
1977-06-28Manufacturing (CMC) · Supplement 20 · standardAP
1976-09-20Labeling · Supplement 19AP
1976-05-10Manufacturing (CMC) · Supplement 18 · standardAP
1976-03-31Manufacturing (CMC) · Supplement 17 · standardAP
1975-10-06Manufacturing (CMC) · Supplement 14 · standardAP
1974-11-15Manufacturing (CMC) · Supplement 12 · standardAP
1974-11-15Labeling · Supplement 10AP
1974-11-15Labeling · Supplement 11AP
1973-06-14Type 1 - New Molecular Entity · 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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