APPLICATION
ANDA077657
TYPE
ANDA
ORIGINAL APPROVAL
2006-03-16
LATEST ACTION
2026-01-05
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
2026-01-05Labeling · Supplement 12 · standardAP
2025-03-26Labeling · Supplement 9 · standardAP
2025-03-26Labeling · Supplement 7 · standardAP
2025-03-26Labeling · Supplement 11 · standardAP
2010-09-08Labeling · Supplement 4AP
2006-03-16OriginalAP
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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