NDA 17854, held by Ani Pharms. Metoclopramide Hydrochloride.
As of Nov 13, 2026, NDA 17854 (Reglan), held by Ani Pharms, was first approved by FDA on Dec 30, 1980, with 52 approved supplements and 0 published complete response letters.
Metoclopramide tablets are indicated for the: Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Limitations of Use: Metoclopramide tablets are not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates.
| Aug 15, 1984 | Supplement 5Efficacy (new indication or use) | Approved | None posted |
| Jun 28, 1982 | Supplement 2Efficacy (new indication or use) | Approved | None posted |
| Dec 30, 1980 | Original applicationNew dosage form · Standard review | Approved | None posted |
| ReglanEQ 10MG BASE · tablet;oral | Metoclopramide Hydrochloride | RxReference drug |
| ReglanEQ 5MG BASE · tablet;oral | Metoclopramide Hydrochloride | RxReference drug |
| Feb 9, 2026 | Supplement 71Labeling · Standard review | Approved | |
| Aug 29, 2017 | Supplement 62Labeling · Standard review | Approved | |
| Jun 15, 2015 | Supplement 61Manufacturing · Standard review | Approved | None posted |
| Apr 17, 2015 | Supplement 60Manufacturing · Standard review | Approved | None posted |
| Jan 12, 2015 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Sep 22, 2011 | Supplement 58Labeling | Approved | |
| Aug 2, 2011 | Supplement 56REMS | Approved | |
| Nov 18, 2010 | Supplement 55Labeling · Standard review | Approved | |
| Sep 4, 2009 | Supplement 52Labeling · Standard review | Approved | |
| Jun 30, 2009 | Supplement 51Labeling · Standard review | Approved | |
| Jul 26, 2004 | Supplement 47Labeling · Standard review | Approved | |
| Apr 22, 2003 | Supplement 45Labeling · Standard review | Approved | |
| Apr 22, 2003 | Supplement 44Labeling · Standard review | Approved | |
| Apr 22, 2003 | Supplement 40Labeling · Standard review | Approved | |
| Nov 7, 2001 | Supplement 41Labeling · Standard review | Approved | |
| Jun 1, 2000 | Supplement 37Labeling · Standard review | Approved | None posted |
| Mar 9, 1999 | Supplement 39Labeling · Standard review | Approved | |
| Feb 3, 1998 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Jun 24, 1996 | Supplement 36Labeling · Standard review | Approved | None posted |
| May 31, 1994 | Supplement 35Labeling · Standard review | Approved | None posted |
| Aug 31, 1992 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1989 | Supplement 34Labeling | Approved | None posted |
| Sep 12, 1988 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| May 5, 1987 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Oct 21, 1986 | Supplement 30Labeling | Approved | None posted |
| Apr 23, 1986 | Supplement 27Labeling | Approved | None posted |
| Apr 15, 1986 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Jan 16, 1986 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Oct 21, 1985 | Supplement 25Labeling | Approved | None posted |
| Aug 20, 1985 | Supplement 24Labeling | Approved | None posted |
| Mar 12, 1985 | Supplement 21Labeling | Approved | None posted |
| Jan 18, 1985 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Sep 21, 1984 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Aug 15, 1984 | Supplement 5Efficacy (new indication or use) | Approved | None posted |
| May 1, 1984 | Supplement 19Labeling | Approved | None posted |
| May 1, 1984 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Jul 27, 1983 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Jul 5, 1983 | Supplement 17Labeling | Approved | None posted |
| May 11, 1983 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Apr 13, 1983 | Supplement 15Labeling | Approved | None posted |
| Nov 12, 1982 | Supplement 14Labeling | Approved | None posted |
| Sep 23, 1982 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Sep 8, 1982 | Supplement 13Labeling | Approved | None posted |
| Jun 28, 1982 | Supplement 2Efficacy (new indication or use) | Approved | None posted |
| Feb 25, 1982 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Feb 19, 1982 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Feb 18, 1982 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Dec 9, 1981 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Nov 6, 1981 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| May 13, 1981 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| May 13, 1981 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| May 13, 1981 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Dec 30, 1980 | Original applicationNew dosage form · Standard review | Approved | None posted |
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
