APPLICATION
ANDA080455
TYPE
ANDA
ORIGINAL APPROVAL
1972-04-26
LATEST ACTION
1998-11-10
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
MEPERIDINE HYDROCHLORIDEPrescription
MEPERIDINE HYDROCHLORIDE 50MG/ML · INJECTABLE · INJECTION
MEPERIDINE HYDROCHLORIDEPrescription
MEPERIDINE HYDROCHLORIDE 100MG/ML · INJECTABLE · INJECTION
MEPERIDINE HYDROCHLORIDEPrescription
MEPERIDINE HYDROCHLORIDE 75MG/ML · INJECTABLE · INJECTION
MEPERIDINE HYDROCHLORIDEPrescription
MEPERIDINE HYDROCHLORIDE 25MG/ML · INJECTABLE · INJECTION
Approval history
1998-11-10Manufacturing (CMC) · Supplement 28AP
1996-01-17Manufacturing (CMC) · Supplement 27AP
1993-07-30Manufacturing (CMC) · Supplement 26AP
1993-07-30Manufacturing (CMC) · Supplement 24AP
1992-03-04Labeling · Supplement 25AP
1990-01-22Labeling · Supplement 23AP
1988-05-23Labeling · Supplement 21AP
1987-03-27Manufacturing (CMC) · Supplement 18AP
1983-12-02Manufacturing (CMC) · Supplement 14AP
1972-04-26OriginalAP
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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