← FDA DRUG APPROVALS

FDA ANDA · ANDA080409

LTA II KIT

Sponsor: HOSPIRA

APPLICATION
ANDA080409
TYPE
ANDA
ORIGINAL APPROVAL
1972-04-06
LATEST ACTION
1992-06-04
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

LTA II KITDiscontinued
LIDOCAINE HYDROCHLORIDE 4% · SOLUTION · TOPICAL

Approval history

1992-06-04Labeling · Supplement 28AP
1992-06-04Labeling · Supplement 14AP
1992-06-04Manufacturing (CMC) · Supplement 13AP
1989-06-13Manufacturing (CMC) · Supplement 27AP
1986-07-25Manufacturing (CMC) · Supplement 26AP
1985-08-09Manufacturing (CMC) · Supplement 25AP
1982-07-19Manufacturing (CMC) · Supplement 22AP
1981-06-24Manufacturing (CMC) · Supplement 21AP
1972-04-06OriginalAP
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 →