APPLICATION
ANDA086996
TYPE
ANDA
ORIGINAL APPROVAL
1981-12-28
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
LANORINALPrescription
ASPIRIN 325MG, BUTALBITAL 50MG, CAFFEINE 40MG · CAPSULE · ORAL
Approval history
2024-11-21Labeling · Supplement 45 · standardAP
2024-10-09Labeling · Supplement 37 · standardAP
2007-08-29Labeling · Supplement 27AP
2007-03-01Labeling · Supplement 25AP
2002-12-09Manufacturing (CMC) · Supplement 20AP
2000-08-10Manufacturing (CMC) · Supplement 18AP
2000-01-12Labeling · Supplement 17AP
1997-11-13Manufacturing (CMC) · Supplement 16AP
1996-04-17Labeling · Supplement 15AP
1996-04-01Manufacturing (CMC) · Supplement 13AP
1996-04-01Manufacturing (CMC) · Supplement 14AP
1993-09-01Manufacturing (CMC) · Supplement 12AP
1991-09-04Manufacturing (CMC) · Supplement 9AP
1990-09-06Labeling · Supplement 11AP
1988-11-17Manufacturing (CMC) · Supplement 7AP
1988-11-17Manufacturing (CMC) · Supplement 8AP
1987-08-25Manufacturing (CMC) · Supplement 6AP
1982-09-10Manufacturing (CMC) · Supplement 2AP
1982-09-10Manufacturing (CMC) · Supplement 1AP
1981-12-28OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.