← FDA DRUG APPROVALS

FDA NDA · NDA022246

METOZOLV ODT

Sponsor: SALIX PHARMS

APPLICATION
NDA022246
TYPE
NDA
ORIGINAL APPROVAL
2009-09-04
LATEST ACTION
2019-02-28
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Discontinued

Products

METOZOLV ODT · ReferenceDiscontinued
METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL
METOZOLV ODT · ReferenceDiscontinued
METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2019-02-28Labeling · Supplement 9 · standard — Letter ↗AP
2011-09-27Labeling · Supplement 6 · unknown — Label ↗AP
2011-08-22REMS · Supplement 5 — Letter ↗AP
2011-08-22Supplement · Supplement 4AP
2010-11-18Labeling · Supplement 1 · unknown — Label ↗AP
2009-09-04Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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