APPLICATION
ANDA040893
TYPE
ANDA
ORIGINAL APPROVAL
2009-06-24
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription
Products
MEPERIDINE HYDROCHLORIDEDiscontinued
MEPERIDINE HYDROCHLORIDE 100MG · TABLET · ORAL
MEPERIDINE HYDROCHLORIDEPrescription
MEPERIDINE HYDROCHLORIDE 50MG · TABLET · ORAL
MEPERIDINE HYDROCHLORIDEDiscontinued
MEPERIDINE HYDROCHLORIDE 150MG · TABLET · ORAL
MEPERIDINE HYDROCHLORIDEDiscontinued
MEPERIDINE HYDROCHLORIDE 75MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 9AP
2025-12-22Labeling · Supplement 8 · standardAP
2024-10-31REMS · Supplement 7AP
2023-12-15Labeling · Supplement 6 · standardAP
2023-12-13Labeling · Supplement 5 · standardAP
2023-12-13Labeling · Supplement 3 · standardAP
2018-09-18REMS · Supplement 4AP
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.
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