APPLICATION
ANDA074282
TYPE
ANDA
ORIGINAL APPROVAL
1994-05-27
LATEST ACTION
2024-08-09
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
LORAZEPAMDiscontinued
LORAZEPAM 2MG/ML · INJECTABLE · INJECTION
LORAZEPAMDiscontinued
LORAZEPAM 4MG/ML · INJECTABLE · INJECTION
Approval history
2024-08-09Labeling · Supplement 26 · standardAP
2022-04-29Labeling · Supplement 23 · standardAP
2020-04-22Labeling · Supplement 19 · standardAP
2020-04-22Labeling · Supplement 18 · standardAP
2007-04-30Labeling · Supplement 7AP
1998-12-09Labeling · Supplement 4AP
1998-12-09Manufacturing (CMC) · Supplement 2AP
1994-05-27OriginalAP
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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