APPLICATION
ANDA040191
TYPE
ANDA
ORIGINAL APPROVAL
1998-12-17
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
MEPERIDINE HYDROCHLORIDEDiscontinued
MEPERIDINE HYDROCHLORIDE 100MG · TABLET · ORAL
MEPERIDINE HYDROCHLORIDEDiscontinued
MEPERIDINE HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 23AP
2026-05-15Labeling · Supplement 22 · standardAP
2025-12-22Labeling · Supplement 21 · standardAP
2024-10-31REMS · Supplement 20AP
2024-07-15Labeling · Supplement 19 · standardAP
2023-12-15Labeling · Supplement 17 · standardAP
2023-12-15Labeling · Supplement 18 · standardAP
2023-12-13Labeling · Supplement 13 · standardAP
2023-12-13Labeling · Supplement 16 · standardAP
2018-09-18REMS · Supplement 14 · standardAP
2015-01-06Labeling · Supplement 8AP
2011-10-18Labeling · Supplement 6AP
2009-07-01Labeling · Supplement 5AP
2005-10-06Labeling · Supplement 4AP
2005-07-07Labeling · Supplement 3AP
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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