Reglan

NDA 18821, held by Robins Ah. Metoclopramide Hydrochloride.

As of Nov 14, 2026, NDA 18821 (Reglan), held by Robins Ah, was first approved by FDA on Mar 25, 1983, with 20 approved supplements and 0 published complete response letters.

First approved: Mar 25, 1983
Review: Standard
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Mar 25, 1983	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
ReglanEQ 5MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;oral	Metoclopramide Hydrochloride	DiscontinuedReference drug

All 21 submissions, including labeling and manufacturing supplements


Nov 12, 2002	Supplement 21Labeling · Standard review	Approved	None posted
Nov 12, 2002	Supplement 19Labeling · Standard review	Approved	None posted
Nov 7, 2001	Supplement 20Labeling · Standard review	Approved	Letter
Jun 1, 2000	Supplement 16Labeling · Standard review	Approved	None posted
Mar 9, 1999	Supplement 18Labeling · Standard review	Approved	Review
Jan 30, 1998	Supplement 17Manufacturing · Standard review	Approved	None posted
Jun 24, 1996	Supplement 15Labeling · Standard review	Approved	None posted
May 31, 1994	Supplement 14Labeling · Standard review	Approved	None posted
Aug 31, 1992	Supplement 12Manufacturing · Standard review	Approved	None posted
Feb 22, 1989	Supplement 13Labeling	Approved	None posted
May 5, 1987	Supplement 10Labeling	Approved	None posted
Nov 4, 1986	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 21, 1986	Supplement 9Labeling	Approved	None posted
Apr 23, 1986	Supplement 7Labeling	Approved	None posted
Oct 21, 1985	Supplement 6Labeling	Approved	None posted
Aug 20, 1985	Supplement 5Labeling	Approved	None posted
Mar 12, 1985	Supplement 4Labeling	Approved	None posted
Sep 23, 1983	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 12, 1983	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 5, 1983	Supplement 1Labeling	Approved	None posted
Mar 25, 1983	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18821
Drugs@FDA: Overview at FDA
Company: Robins Ah

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