APPLICATION
ANDA088640
TYPE
ANDA
ORIGINAL APPROVAL
1984-09-19
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
MEPERIDINE HYDROCHLORIDEDiscontinued
MEPERIDINE HYDROCHLORIDE 100MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 55AP
2025-12-22Labeling · Supplement 52 · standardAP
2024-10-31REMS · Supplement 51AP
2024-04-16Labeling · Supplement 50 · standardAP
2023-12-18Labeling · Supplement 49 · standardAP
2023-12-18Labeling · Supplement 48 · standardAP
2023-07-17Labeling · Supplement 47 · standardAP
2023-07-17Labeling · Supplement 43 · standardAP
2023-07-17Labeling · Supplement 41 · standardAP
2018-09-18REMS · Supplement 42AP
2015-05-29Labeling · Supplement 37AP
2015-05-29Labeling · Supplement 36AP
2009-09-02Labeling · Supplement 33AP
2004-03-02Labeling · Supplement 29AP
2001-07-09Manufacturing (CMC) · Supplement 27AP
2001-07-09Manufacturing (CMC) · Supplement 28AP
2000-10-30Manufacturing (CMC) · Supplement 25AP
1999-12-21Manufacturing (CMC) · Supplement 24AP
1999-05-20Manufacturing (CMC) · Supplement 23AP
1999-03-12Manufacturing (CMC) · Supplement 22AP
1998-12-01Manufacturing (CMC) · Supplement 21AP
1996-10-04Manufacturing (CMC) · Supplement 19AP
1996-10-04Manufacturing (CMC) · Supplement 17AP
1996-10-04Manufacturing (CMC) · Supplement 18AP
1996-10-04Manufacturing (CMC) · Supplement 20AP
1994-12-23Manufacturing (CMC) · Supplement 16AP
1994-03-02Labeling · Supplement 15AP
1992-04-03Manufacturing (CMC) · Supplement 12AP
1992-04-03Manufacturing (CMC) · Supplement 14AP
1991-09-27Labeling · Supplement 53AP
1991-09-27Labeling · Supplement 11AP
1991-08-30Manufacturing (CMC) · Supplement 10AP
1991-08-30Manufacturing (CMC) · Supplement 9AP
1989-10-27Labeling · Supplement 8AP
1989-08-28Labeling · Supplement 7AP
1987-04-01Manufacturing (CMC) · Supplement 4AP
1985-05-02Manufacturing (CMC) · Supplement 2AP
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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