APPLICATION
NDA050667
TYPE
NDA
ORIGINAL APPROVAL
1991-12-31
LATEST ACTION
2001-09-27
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued
Products
LORABIDDiscontinued
LORACARBEF 100MG/5ML · FOR SUSPENSION · ORAL
LORABIDDiscontinued
LORACARBEF 200MG/5ML · FOR SUSPENSION · ORAL
Approval history
2001-09-27Labeling · Supplement 22 · standardAP
2001-05-11Labeling · Supplement 20 · standardAP
2000-10-05Labeling · Supplement 18 · standardAP
2000-09-12Manufacturing (CMC) · Supplement 21 · standardAP
1999-11-08Manufacturing (CMC) · Supplement 19 · standardAP
1997-08-01Manufacturing (CMC) · Supplement 15 · standardAP
1996-11-26Manufacturing (CMC) · Supplement 16 · standardAP
1996-11-12Manufacturing (CMC) · Supplement 17 · standardAP
1996-07-09Manufacturing (CMC) · Supplement 14 · standardAP
1996-03-14Manufacturing (CMC) · Supplement 13 · standardAP
1996-02-21Manufacturing (CMC) · Supplement 10 · standardAP
1995-02-08Labeling · Supplement 8 · standardAP
1995-02-08Labeling · Supplement 9 · standardAP
1994-06-24Manufacturing (CMC) · Supplement 6 · standardAP
1993-09-02Manufacturing (CMC) · Supplement 4 · standardAP
1993-03-08Manufacturing (CMC) · Supplement 5 · standardAP
1993-02-16Manufacturing (CMC) · Supplement 3 · standardAP
1992-12-30Labeling · Supplement 2 · standardAP
1991-12-31Type 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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