Reglan Odt

NDA 21793, held by Meda Pharms. Metoclopramide Hydrochloride.

As of Nov 14, 2026, NDA 21793 (Reglan Odt), held by Meda Pharms, was first approved by FDA on Jun 10, 2005, with 6 approved supplements and 0 published complete response letters.

First approved: Jun 10, 2005
Review: Standard
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Jun 10, 2005	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Reglan OdtEQ 5MG BASE · tablet, orally disintegrating;oral	Metoclopramide Hydrochloride	Discontinued
Reglan OdtEQ 10MG BASE · tablet, orally disintegrating;oral	Metoclopramide Hydrochloride	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Nov 30, 2011	Supplement 11Labeling · Standard review	Approved	Label Medication Guide Letter
Aug 2, 2011	Supplement 9Labeling · Standard review	Approved	Letter
Nov 18, 2010	Supplement 8Labeling · Standard review	Approved	Label Letter
Sep 9, 2010	Supplement 7Labeling · Standard review	Approved	Letter Label
Sep 4, 2009	Supplement 5Labeling · Standard review	Approved	Letter
Jun 30, 2009	Supplement 4Labeling · Standard review	Approved	Review Label Letter
Jun 10, 2005	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21793
Drugs@FDA: Overview at FDA
Company: Meda Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters