APPLICATION
ANDA074243
TYPE
ANDA
ORIGINAL APPROVAL
1994-04-12
LATEST ACTION
2023-09-25
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
LORAZEPAMPrescription
LORAZEPAM 4MG/ML · INJECTABLE · INJECTION
LORAZEPAMPrescription
LORAZEPAM 2MG/ML · INJECTABLE · INJECTION
Approval history
2023-09-25Labeling · Supplement 45 · standardAP
2022-04-29Labeling · Supplement 41 · standardAP
2020-06-09Labeling · Supplement 18 · standardAP
2020-06-09Labeling · Supplement 19 · standardAP
2014-05-13Manufacturing (CMC) · Supplement 16AP
2007-04-27Labeling · Supplement 6AP
2002-03-05Manufacturing (CMC) · Supplement 5AP
2001-02-14Manufacturing (CMC) · Supplement 4AP
1999-04-21Labeling · Supplement 3AP
1999-04-21Manufacturing (CMC) · Supplement 2AP
1995-12-22Manufacturing (CMC) · Supplement 1AP
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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