APPLICATION
ANDA080445
TYPE
ANDA
ORIGINAL APPROVAL
1975-01-22
LATEST ACTION
2024-10-11
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
MEPERIDINE HYDROCHLORIDEPrescription
MEPERIDINE HYDROCHLORIDE 25MG/ML · INJECTABLE · INJECTION
MEPERIDINE HYDROCHLORIDEPrescription
MEPERIDINE HYDROCHLORIDE 100MG/ML · INJECTABLE · INJECTION
MEPERIDINE HYDROCHLORIDEPrescription
MEPERIDINE HYDROCHLORIDE 50MG/ML · INJECTABLE · INJECTION
MEPERIDINE HYDROCHLORIDEPrescription
MEPERIDINE HYDROCHLORIDE 75MG/ML · INJECTABLE · INJECTION
Approval history
2024-10-11Labeling · Supplement 52 · standardAP
2023-08-10Labeling · Supplement 45 · standardAP
2023-08-10Labeling · Supplement 51 · standardAP
2005-04-28Labeling · Supplement 38AP
2002-04-10Manufacturing (CMC) · Supplement 35AP
1996-04-30Manufacturing (CMC) · Supplement 26AP
1995-09-22Manufacturing (CMC) · Supplement 22AP
1992-03-13Labeling · Supplement 21AP
1991-10-16Labeling · Supplement 20AP
1991-04-03Labeling · Supplement 19AP
1990-12-18Labeling · Supplement 18AP
1989-09-19Labeling · Supplement 17AP
1989-07-20Labeling · Supplement 16AP
1988-12-28Labeling · Supplement 14AP
1986-11-03Manufacturing (CMC) · Supplement 11AP
1983-03-08Manufacturing (CMC) · Supplement 10AP
1975-01-22OriginalAP
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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