APPLICATION
NDA018821
TYPE
NDA
ORIGINAL APPROVAL
1983-03-25
LATEST ACTION
2002-11-12
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
REGLAN · ReferenceDiscontinued
METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL
Approval history
2002-11-12Labeling · Supplement 21 · standardAP
2002-11-12Labeling · Supplement 19 · standardAP
2000-06-01Labeling · Supplement 16 · standardAP
1998-01-30Manufacturing (CMC) · Supplement 17 · standardAP
1996-06-24Labeling · Supplement 15 · standardAP
1994-05-31Labeling · Supplement 14 · standardAP
1992-08-31Manufacturing (CMC) · Supplement 12 · standardAP
1989-02-22Labeling · Supplement 13AP
1987-05-05Labeling · Supplement 10AP
1986-11-04Manufacturing (CMC) · Supplement 8 · standardAP
1986-10-21Labeling · Supplement 9AP
1986-04-23Labeling · Supplement 7AP
1985-10-21Labeling · Supplement 6AP
1985-08-20Labeling · Supplement 5AP
1985-03-12Labeling · Supplement 4AP
1983-09-23Manufacturing (CMC) · Supplement 3 · standardAP
1983-08-12Manufacturing (CMC) · Supplement 2 · standardAP
1983-07-05Labeling · Supplement 1AP
1983-03-25Type 3 - New Dosage Form · Original · standardAP
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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