← FDA DRUG APPROVALS

FDA ANDA · ANDA071195

LORAZEPAM

Sponsor: SANDOZ

APPLICATION
ANDA071195
TYPE
ANDA
ORIGINAL APPROVAL
1988-04-15
LATEST ACTION
2024-02-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LORAZEPAMDiscontinued
LORAZEPAM 2MG · TABLET · ORAL

Approval history

2024-02-29Labeling · Supplement 28 · standardAP
2007-12-04Labeling · Supplement 21AP
2002-03-07Manufacturing (CMC) · Supplement 15AP
2001-09-21Manufacturing (CMC) · Supplement 14AP
2000-10-31Manufacturing (CMC) · Supplement 13AP
2000-05-24Manufacturing (CMC) · Supplement 12AP
1999-05-05Manufacturing (CMC) · Supplement 10AP
1997-09-25Manufacturing (CMC) · Supplement 9AP
1997-08-11Manufacturing (CMC) · Supplement 8AP
1994-01-24Manufacturing (CMC) · Supplement 7AP
1993-04-15Labeling · Supplement 6AP
1992-05-18Manufacturing (CMC) · Supplement 4AP
1990-03-09Labeling · Supplement 5AP
1989-09-27Labeling · Supplement 3AP
1989-01-26Labeling · Supplement 2AP
1988-08-18Labeling · Supplement 1AP
1988-04-15OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →