APPLICATION
ANDA073118
TYPE
ANDA
ORIGINAL APPROVAL
1991-01-17
LATEST ACTION
2015-06-02
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
METOCLOPRAMIDE HYDROCHLORIDEPrescription
METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML · INJECTABLE · INJECTION
Approval history
2015-06-02Labeling · Supplement 28 · standardAP
2015-06-02Labeling · Supplement 26AP
2006-04-03Labeling · Supplement 18AP
2003-05-05Labeling · Supplement 16AP
2002-12-09Labeling · Supplement 15AP
2002-10-25Manufacturing (CMC) · Supplement 14AP
2002-02-01Labeling · Supplement 13AP
2001-03-22Manufacturing (CMC) · Supplement 11AP
2001-03-22Manufacturing (CMC) · Supplement 12AP
2000-01-07Labeling · Supplement 9AP
2000-01-07Manufacturing (CMC) · Supplement 8AP
1999-09-13Labeling · Supplement 10AP
1997-11-25Labeling · Supplement 7AP
1996-10-22Manufacturing (CMC) · Supplement 4AP
1996-10-03Manufacturing (CMC) · Supplement 5AP
1996-02-07Manufacturing (CMC) · Supplement 1AP
1995-11-30Labeling · Supplement 2AP
1991-01-17OriginalAP
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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