APPLICATION
ANDA040186
TYPE
ANDA
ORIGINAL APPROVAL
1997-06-30
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
MEPERIDINE HYDROCHLORIDEDiscontinued
MEPERIDINE HYDROCHLORIDE 50MG · TABLET · ORAL
MEPERIDINE HYDROCHLORIDEDiscontinued
MEPERIDINE HYDROCHLORIDE 100MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 16AP
2025-12-22Labeling · Supplement 15 · standardAP
2024-10-31REMS · Supplement 14AP
2024-04-30Labeling · Supplement 13 · standardAP
2023-12-15Labeling · Supplement 12 · standardAP
2023-12-15Labeling · Supplement 11 · standardAP
2023-12-13Labeling · Supplement 10 · standardAP
2018-09-18REMS · Supplement 9AP
2004-08-16Labeling · Supplement 6AP
2001-04-12Manufacturing (CMC) · Supplement 5AP
2000-03-21Manufacturing (CMC) · Supplement 4AP
1998-08-21Manufacturing (CMC) · Supplement 3AP
1997-10-22Manufacturing (CMC) · Supplement 2AP
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.