APPLICATION
NDA017854
TYPE
NDA
ORIGINAL APPROVAL
1980-12-30
LATEST ACTION
2026-02-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
REGLAN · ReferencePrescription
METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE · TABLET · ORAL
REGLAN · ReferencePrescription
METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
Approval history
2015-06-15Manufacturing (CMC) · Supplement 61 · standardAP
2015-04-17Manufacturing (CMC) · Supplement 60 · standardAP
2015-01-12Manufacturing (CMC) · Supplement 59 · standardAP
2000-06-01Labeling · Supplement 37 · standardAP
1998-02-03Manufacturing (CMC) · Supplement 38 · standardAP
1996-06-24Labeling · Supplement 36 · standardAP
1994-05-31Labeling · Supplement 35 · standardAP
1992-08-31Manufacturing (CMC) · Supplement 33 · standardAP
1989-02-22Labeling · Supplement 34AP
1988-09-12Manufacturing (CMC) · Supplement 31 · standardAP
1987-05-05Manufacturing (CMC) · Supplement 29 · standardAP
1986-10-21Labeling · Supplement 30AP
1986-04-23Labeling · Supplement 27AP
1986-04-15Manufacturing (CMC) · Supplement 28 · standardAP
1986-01-16Manufacturing (CMC) · Supplement 26 · standardAP
1985-10-21Labeling · Supplement 25AP
1985-08-20Labeling · Supplement 24AP
1985-03-12Labeling · Supplement 21AP
1985-01-18Manufacturing (CMC) · Supplement 22 · standardAP
1984-09-21Manufacturing (CMC) · Supplement 20 · standardAP
1984-08-15Efficacy · Supplement 5AP
1984-05-01Labeling · Supplement 19AP
1984-05-01Manufacturing (CMC) · Supplement 18 · standardAP
1983-07-27Manufacturing (CMC) · Supplement 12 · standardAP
1983-07-05Labeling · Supplement 17AP
1983-05-11Manufacturing (CMC) · Supplement 16 · standardAP
1983-04-13Labeling · Supplement 15AP
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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