← FDA DRUG APPROVALS

FDA ANDA · ANDA086986

LANORINAL

Sponsor: LANNETT

APPLICATION
ANDA086986
TYPE
ANDA
ORIGINAL APPROVAL
1982-07-01
LATEST ACTION
1991-09-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LANORINALDiscontinued
ASPIRIN 325MG, BUTALBITAL 50MG, CAFFEINE 40MG · TABLET · ORAL

Approval history

1991-09-04Manufacturing (CMC) · Supplement 4AP
1990-10-01Labeling · Supplement 7AP
1988-03-04Labeling · Supplement 5AP
1985-10-18Manufacturing (CMC) · Supplement 3AP
1985-10-18Manufacturing (CMC) · Supplement 1AP
1985-10-18Manufacturing (CMC) · Supplement 2AP
1982-07-01OriginalAP
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 →