APPLICATION
ANDA040331
TYPE
ANDA
ORIGINAL APPROVAL
1999-05-28
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MEPERIDINE HYDROCHLORIDEPrescription
MEPERIDINE HYDROCHLORIDE 50MG · TABLET · ORAL
MEPERIDINE HYDROCHLORIDEPrescription
MEPERIDINE HYDROCHLORIDE 100MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 25AP
2025-12-22Labeling · Supplement 24 · standardAP
2024-10-31REMS · Supplement 23AP
2024-04-12Labeling · Supplement 21 · standardAP
2024-04-12Labeling · Supplement 22 · standardAP
2024-03-22Labeling · Supplement 20 · standardAP
2020-12-17Labeling · Supplement 17 · standardAP
2020-12-17Labeling · Supplement 15 · standardAP
2020-12-17Manufacturing (CMC) · Supplement 18 · standardAP
2018-09-18REMS · Supplement 16AP
2013-10-21Labeling · Supplement 14 · standardAP
2012-08-31Labeling · Supplement 10AP
2004-12-17Labeling · Supplement 6AP
2004-09-07Labeling · Supplement 4AP
2004-06-03Labeling · 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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