APPLICATION
ANDA074300
TYPE
ANDA
ORIGINAL APPROVAL
1994-04-12
LATEST ACTION
2005-06-29
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
LORAZEPAMDiscontinued
LORAZEPAM 4MG/ML · INJECTABLE · INJECTION
LORAZEPAMDiscontinued
LORAZEPAM 2MG/ML · INJECTABLE · INJECTION
Approval history
2005-06-29Labeling · Supplement 6AP
2002-03-05Manufacturing (CMC) · Supplement 5AP
2001-02-14Manufacturing (CMC) · Supplement 4AP
1998-12-09Labeling · Supplement 3AP
1997-03-19Manufacturing (CMC) · Supplement 1AP
1997-03-19Labeling · Supplement 2AP
1994-04-12OriginalAP
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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