APPLICATION
ANDA071591
TYPE
ANDA
ORIGINAL APPROVAL
1987-10-13
LATEST ACTION
2025-08-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LORAZEPAMDiscontinued
LORAZEPAM 1MG · TABLET · ORAL
LORAZEPAMDiscontinued
LORAZEPAM 2MG · TABLET · ORAL
LORAZEPAMDiscontinued
LORAZEPAM 0.5MG · TABLET · ORAL
Approval history
2025-08-18Labeling · Supplement 13 · standardAP
2025-08-18Labeling · Supplement 11 · standardAP
1998-02-05Manufacturing (CMC) · Supplement 7AP
1993-10-18Manufacturing (CMC) · Supplement 6AP
1993-06-10Labeling · Supplement 4AP
1991-05-31Labeling · Supplement 3AP
1990-01-31Manufacturing (CMC) · Supplement 2AP
1987-10-13OriginalAP
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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