APPLICATION
NDA050668
TYPE
NDA
ORIGINAL APPROVAL
1991-12-31
LATEST ACTION
2001-05-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
LORABIDDiscontinued
LORACARBEF 200MG · CAPSULE · ORAL
LORABIDDiscontinued
LORACARBEF 400MG · CAPSULE · ORAL
Approval history
2001-05-11Labeling · Supplement 22 · standardAP
2000-11-29Manufacturing (CMC) · Supplement 24 · standardAP
2000-10-05Labeling · Supplement 19 · standardAP
2000-07-27Manufacturing (CMC) · Supplement 23 · standardAP
1999-11-08Manufacturing (CMC) · Supplement 21 · standardAP
1999-02-18Manufacturing (CMC) · Supplement 20 · standardAP
1996-11-26Manufacturing (CMC) · Supplement 18 · standardAP
1996-05-15Labeling · Supplement 16 · standardAP
1996-04-25Manufacturing (CMC) · Supplement 17 · standardAP
1996-04-25Manufacturing (CMC) · Supplement 15 · standardAP
1996-04-05Labeling · Supplement 7 · standardAP
1996-01-25Manufacturing (CMC) · Supplement 12 · standardAP
1995-02-14Manufacturing (CMC) · Supplement 8 · standardAP
1994-06-30Manufacturing (CMC) · Supplement 10 · standardAP
1993-12-07Manufacturing (CMC) · Supplement 5 · standardAP
1993-09-22Manufacturing (CMC) · Supplement 6 · standardAP
1993-09-17Manufacturing (CMC) · Supplement 4 · standardAP
1992-12-30Labeling · Supplement 3 · standardAP
1992-03-30Manufacturing (CMC) · Supplement 1 · standardAP
1991-12-31Type 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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