APPLICATION
ANDA040110
TYPE
ANDA
ORIGINAL APPROVAL
1997-03-12
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 14 · standardAP
2024-10-31REMS · Supplement 13AP
2024-08-13Labeling · Supplement 12 · standardAP
2023-12-15Labeling · Supplement 11 · standardAP
2023-12-14Labeling · Supplement 10 · standardAP
2021-03-04Labeling · Supplement 9 · standardAP
2019-10-08Labeling · Supplement 8 · standardAP
2019-10-04Labeling · Supplement 7 · standardAP
2018-09-18REMS · Supplement 6AP
2017-04-28Labeling · Supplement 5 · standardAP
2012-03-30Labeling · Supplement 4AP
2011-05-17Labeling · Supplement 3AP
2009-04-28Labeling · Supplement 2AP
2005-09-26Labeling · Supplement 1AP
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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