← FDA DRUG APPROVALS

FDA NDA · NDA018140

LORAZEPAM

Sponsor: HIKMA

APPLICATION
NDA018140
TYPE
NDA
ORIGINAL APPROVAL
1980-07-25
LATEST ACTION
2023-01-13
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ATIVAN · ReferencePrescription
LORAZEPAM 4MG/ML · INJECTABLE · INJECTION
ATIVAN · ReferencePrescription
LORAZEPAM 2MG/ML · INJECTABLE · INJECTION

Approval history

2023-01-13Labeling · Supplement 51 · standard — Letter ↗AP
2021-02-05Labeling · Supplement 46 · 901 required — Letter ↗AP
2017-04-27Labeling · Supplement 42 · 901 required — Letter ↗AP
2017-04-27Labeling · Supplement 41 · 901 required — Letter ↗AP
2016-05-27Labeling · Supplement 40 · standard — Label ↗AP
2016-04-18Manufacturing (CMC) · Supplement 38 · standardAP
2015-10-02Manufacturing (CMC) · Supplement 39 · standardAP
2006-11-29Labeling · Supplement 28 · standard — Letter ↗AP
2001-12-12Labeling · Supplement 27 · standard — Review ↗AP
2000-09-26Labeling · Supplement 26 · standardAP
1998-10-16Manufacturing (CMC) · Supplement 24 · standardAP
1997-11-04Manufacturing (CMC) · Supplement 25 · standardAP
1997-09-05Efficacy · Supplement 3 — Review ↗AP
1996-09-26Manufacturing (CMC) · Supplement 23 · standardAP
1996-03-19Labeling · Supplement 22 · standardAP
1996-03-19Labeling · Supplement 12AP
1996-03-19Labeling · Supplement 9AP
1996-03-19Labeling · Supplement 11AP
1995-03-08Manufacturing (CMC) · Supplement 21 · standardAP
1995-01-06Manufacturing (CMC) · Supplement 20 · standardAP
1993-09-29Manufacturing (CMC) · Supplement 18 · standardAP
1993-09-29Manufacturing (CMC) · Supplement 19 · standardAP
1993-06-03Manufacturing (CMC) · Supplement 17 · standardAP
1992-08-18Manufacturing (CMC) · Supplement 16 · standardAP
1991-06-26Manufacturing (CMC) · Supplement 15 · standardAP
1991-01-02Manufacturing (CMC) · Supplement 14 · standardAP
1989-11-03Manufacturing (CMC) · Supplement 13 · standardAP
1989-06-13Manufacturing (CMC) · Supplement 10 · standardAP
1987-04-24Manufacturing (CMC) · Supplement 7 · standardAP
1987-04-13Labeling · Supplement 8AP
1984-02-14Manufacturing (CMC) · Supplement 6 · standardAP
1984-02-14Manufacturing (CMC) · Supplement 5 · standardAP
1983-06-14Manufacturing (CMC) · Supplement 4 · standardAP
1981-02-02Manufacturing (CMC) · Supplement 2 · standardAP
1980-09-09Labeling · Supplement 1AP
1980-07-25Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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