APPLICATION
ANDA080448
TYPE
ANDA
ORIGINAL APPROVAL
1976-10-15
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 26AP
2025-12-22Labeling · Supplement 25 · standardAP
2024-10-31REMS · Supplement 24AP
2024-04-30Labeling · Supplement 23 · standardAP
2023-12-15Labeling · Supplement 22 · standardAP
2018-09-18REMS · Supplement 21AP
1992-05-08Labeling · Supplement 18AP
1989-03-16Labeling · Supplement 17AP
1986-08-14Manufacturing (CMC) · Supplement 15AP
1983-10-28Manufacturing (CMC) · Supplement 13AP
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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