APPLICATION
ANDA070184
TYPE
ANDA
ORIGINAL APPROVAL
1985-07-29
LATEST ACTION
2019-07-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METOCLOPRAMIDE HYDROCHLORIDEPrescription
METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
Approval history
2019-07-16Labeling · Supplement 69 · standardAP
2014-12-10Labeling · Supplement 66AP
2014-07-28Manufacturing (CMC) · Supplement 61AP
2011-02-28Labeling · Supplement 63AP
2010-03-31REMS · Supplement 62AP
2009-11-16Labeling · Supplement 60AP
2007-01-17Labeling · Supplement 55AP
2002-08-12Labeling · Supplement 44AP
2001-11-13Manufacturing (CMC) · Supplement 43AP
2001-10-24Manufacturing (CMC) · Supplement 42AP
2001-01-29Labeling · Supplement 41AP
2000-07-07Manufacturing (CMC) · Supplement 40AP
2000-01-27Manufacturing (CMC) · Supplement 37AP
1999-12-22Labeling · Supplement 39AP
1999-10-27Labeling · Supplement 38AP
1999-03-26Manufacturing (CMC) · Supplement 36AP
1998-05-20Manufacturing (CMC) · Supplement 35AP
1997-06-18Manufacturing (CMC) · Supplement 34AP
1996-03-11Labeling · Supplement 33AP
1995-02-17Manufacturing (CMC) · Supplement 32AP
1995-02-16Manufacturing (CMC) · Supplement 30AP
1994-10-20Manufacturing (CMC) · Supplement 28AP
1994-09-06Manufacturing (CMC) · Supplement 29AP
1994-06-17Manufacturing (CMC) · Supplement 27AP
1994-03-10Labeling · Supplement 26AP
1993-09-21Labeling · Supplement 25AP
1993-08-05Manufacturing (CMC) · Supplement 18AP
1993-03-18Labeling · Supplement 24AP
1992-06-17Labeling · Supplement 23AP
1991-03-12Labeling · Supplement 22AP
1990-09-06Labeling · Supplement 19AP
1989-03-16Manufacturing (CMC) · Supplement 10AP
1988-12-16Labeling · Supplement 17AP
1988-12-06Labeling · Supplement 16AP
1988-09-23Manufacturing (CMC) · Supplement 15AP
1987-10-26Manufacturing (CMC) · Supplement 12AP
1987-03-09Manufacturing (CMC) · Supplement 9AP
1986-11-05Manufacturing (CMC) · Supplement 8AP
1986-11-05Manufacturing (CMC) · Supplement 6AP
1986-11-05Manufacturing (CMC) · Supplement 5AP
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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