APPLICATION
ANDA088744
TYPE
ANDA
ORIGINAL APPROVAL
1985-01-30
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Prescription
Products
MEPERIDINE HYDROCHLORIDEPrescription
MEPERIDINE HYDROCHLORIDE 50MG/5ML · SYRUP · ORAL
Approval history
2026-06-18REMS · Supplement 38AP
2025-12-22Labeling · Supplement 35 · standardAP
2024-10-31REMS · Supplement 34AP
2024-08-13Labeling · Supplement 33 · standardAP
2023-12-15Labeling · Supplement 32 · standardAP
2023-12-14Labeling · Supplement 31 · standardAP
2021-03-04Labeling · Supplement 30 · standardAP
2019-10-08Labeling · Supplement 29 · standardAP
2019-10-04Labeling · Supplement 28 · standardAP
2018-09-18REMS · Supplement 27AP
2017-04-28Labeling · Supplement 26 · standardAP
2012-03-30Labeling · Supplement 23AP
2011-05-18Labeling · Supplement 22AP
2009-04-28Labeling · Supplement 21AP
2005-09-26Labeling · Supplement 19AP
1999-06-24Manufacturing (CMC) · Supplement 18AP
1999-06-24Manufacturing (CMC) · Supplement 16AP
1997-11-14Manufacturing (CMC) · Supplement 14AP
1997-11-14Manufacturing (CMC) · Supplement 15AP
1997-01-10Manufacturing (CMC) · Supplement 10AP
1997-01-10Labeling · Supplement 11AP
1997-01-10Manufacturing (CMC) · Supplement 9AP
1996-08-28Manufacturing (CMC) · Supplement 13AP
1996-08-07Manufacturing (CMC) · Supplement 12AP
1990-04-05Labeling · Supplement 4AP
1988-09-19Manufacturing (CMC) · Supplement 1AP
1988-09-19Manufacturing (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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