FDA NDA · NDA021793

REGLAN ODT

Sponsor: MEDA PHARMS

APPLICATION

NDA021793

TYPE

NDA

ORIGINAL APPROVAL

2005-06-10

LATEST ACTION

2011-11-30

ROUTE

ORAL

DOSAGE FORM

TABLET, ORALLY DISINTEGRATING

MARKETING STATUS

Discontinued

Products

REGLAN ODTDiscontinued

METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG BASE · TABLET, ORALLY DISINTEGRATING · ORAL

REGLAN ODTDiscontinued

METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE · TABLET, ORALLY DISINTEGRATING · ORAL

2011-11-30Labeling · Supplement 11 · standard — Label ↗AP

2011-08-02Labeling · Supplement 9 · standard — Letter ↗AP

2010-11-18Labeling · Supplement 8 · standard — Label ↗AP

2010-09-09Labeling · Supplement 7 · standard — Label ↗AP

2009-09-04Labeling · Supplement 5 · standard — Letter ↗AP

2009-06-30Labeling · Supplement 4 · standard — Review ↗AP

2005-06-10Type 3 - New Dosage Form · Original · standard — Label ↗AP

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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