APPLICATION
ANDA072755
TYPE
ANDA
ORIGINAL APPROVAL
1991-06-28
LATEST ACTION
2022-04-06
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Prescription
Products
LORAZEPAM INTENSOLPrescription
LORAZEPAM 2MG/ML · CONCENTRATE · ORAL
Approval history
2022-04-06Labeling · Supplement 17 · standardAP
2017-09-27Manufacturing (CMC) · Supplement 16 · unknownAP
2007-10-29Labeling · Supplement 14AP
2007-09-14Labeling · Supplement 11AP
2001-04-20Manufacturing (CMC) · Supplement 7AP
2001-02-14Manufacturing (CMC) · Supplement 6AP
1996-08-28Manufacturing (CMC) · Supplement 5AP
1994-03-08Labeling · Supplement 3AP
1991-06-28OriginalAP
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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