APPLICATION
ANDA074535
TYPE
ANDA
ORIGINAL APPROVAL
1996-09-12
LATEST ACTION
2000-12-08
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
LORAZEPAMDiscontinued
LORAZEPAM 4MG/ML · INJECTABLE · INJECTION
LORAZEPAMDiscontinued
LORAZEPAM 2MG/ML · INJECTABLE · INJECTION
Approval history
2000-12-08Manufacturing (CMC) · Supplement 6AP
2000-07-11Manufacturing (CMC) · Supplement 5AP
2000-04-28Manufacturing (CMC) · Supplement 3AP
1999-11-01Manufacturing (CMC) · Supplement 4AP
1999-06-17Labeling · Supplement 2AP
1997-06-10Manufacturing (CMC) · Supplement 1AP
1996-09-12OriginalAP
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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