APPLICATION
ANDA074276
TYPE
ANDA
ORIGINAL APPROVAL
1994-04-15
LATEST ACTION
2005-04-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
LORAZEPAMDiscontinued
LORAZEPAM 2MG/ML · INJECTABLE · INJECTION
LORAZEPAMDiscontinued
LORAZEPAM 4MG/ML · INJECTABLE · INJECTION
Approval history
2005-04-05Labeling · Supplement 6AP
1999-02-19Manufacturing (CMC) · Supplement 5AP
1999-02-02Manufacturing (CMC) · Supplement 3AP
1996-08-16Manufacturing (CMC) · Supplement 2AP
1996-02-13Manufacturing (CMC) · Supplement 1AP
1994-04-15OriginalAP
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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