APPLICATION
ANDA072555
TYPE
ANDA
ORIGINAL APPROVAL
1991-03-29
LATEST ACTION
2007-08-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LORAZEPAMDiscontinued
LORAZEPAM 0.5MG · TABLET · ORAL
LORAZEPAMDiscontinued
LORAZEPAM 1MG · TABLET · ORAL
LORAZEPAMDiscontinued
LORAZEPAM 2MG · TABLET · ORAL
Approval history
2007-08-14Labeling · Supplement 23AP
2002-12-31Manufacturing (CMC) · Supplement 14AP
2002-04-15Manufacturing (CMC) · Supplement 13AP
2002-04-15Manufacturing (CMC) · Supplement 12AP
2002-01-24Manufacturing (CMC) · Supplement 11AP
2000-10-02Manufacturing (CMC) · Supplement 9AP
2000-10-02Labeling · Supplement 10AP
2000-05-16Manufacturing (CMC) · Supplement 8AP
2000-05-16Manufacturing (CMC) · Supplement 7AP
1997-12-05Manufacturing (CMC) · Supplement 6AP
1997-02-24Manufacturing (CMC) · Supplement 5AP
1996-08-28Manufacturing (CMC) · Supplement 4AP
1995-06-22Manufacturing (CMC) · Supplement 3AP
1993-06-22Labeling · Supplement 1AP
1991-03-29OriginalAP
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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