NDA 17862, held by Hikma. Metoclopramide Hydrochloride.
As of Nov 13, 2026, NDA 17862 (Reglan), held by Hikma, was first approved by FDA on Feb 7, 1979, with 47 approved supplements and 0 published complete response letters.
| May 28, 1987 | Supplement 21Efficacy (new indication or use) | Approved | None posted |
| Jul 5, 1983 | Supplement 20Efficacy (new indication or use) | Approved | None posted |
| Jun 28, 1982 | Supplement 6Efficacy (new indication or use) | Approved | None posted |
| Feb 19, 1982 | Supplement 9Efficacy (new indication or use) | Approved | None posted |
| Jan 22, 1981 | Supplement 3Efficacy (new indication or use) | Approved | None posted |
| Feb 7, 1979 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| ReglanEQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Metoclopramide Hydrochloride | DiscontinuedReference drug |
| ReglanEQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Metoclopramide Hydrochloride | Discontinued |
| Feb 9, 2026 | Supplement 64Labeling · Standard review | Approved | |
| Nov 18, 2010 | Supplement 63Labeling | Approved | |
| Jun 30, 2009 | Supplement 61Labeling | Approved | |
| Apr 19, 2004 | Supplement 51Labeling · Standard review | Approved | |
| Apr 19, 2004 | Supplement 50Labeling · Standard review | Approved | |
| Nov 7, 2001 | Supplement 48Labeling · Standard review | Approved | |
| Jan 29, 2001 | Supplement 47Manufacturing · Priority review | Approved | None posted |
| Jan 22, 2001 | Supplement 46Manufacturing · Priority review | Approved | None posted |
| Jan 22, 2001 | Supplement 45Manufacturing · Priority review | Approved | None posted |
| Jun 1, 2000 | Supplement 40Labeling · Standard review | Approved | None posted |
| Aug 27, 1999 | Supplement 43Manufacturing · Priority review | Approved | None posted |
| Mar 9, 1999 | Supplement 42Labeling · Standard review | Approved | |
| Jan 30, 1998 | Supplement 41Manufacturing · Priority review | Approved | None posted |
| Jun 24, 1996 | Supplement 39Labeling · Standard review | Approved | None posted |
| May 31, 1994 | Supplement 38Labeling · Standard review | Approved | None posted |
| Aug 31, 1992 | Supplement 35Manufacturing · Priority review | Approved | None posted |
| Feb 16, 1990 | Supplement 37Manufacturing · Priority review | Approved | None posted |
| Feb 22, 1989 | Supplement 36Labeling | Approved | None posted |
| Sep 12, 1988 | Supplement 33Manufacturing · Priority review | Approved | None posted |
| Sep 15, 1987 | Supplement 32Labeling | Approved | None posted |
| May 28, 1987 | Supplement 29Manufacturing · Priority review | Approved | None posted |
| May 28, 1987 | Supplement 21Efficacy (new indication or use) | Approved | None posted |
| Apr 17, 1987 | Supplement 31Manufacturing · Priority review | Approved | None posted |
| Oct 23, 1986 | Supplement 30Labeling | Approved | None posted |
| Nov 20, 1985 | Supplement 26Manufacturing · Priority review | Approved | None posted |
| Oct 21, 1985 | Supplement 25Labeling | Approved | None posted |
| Aug 20, 1985 | Supplement 24Labeling | Approved | None posted |
| Mar 12, 1985 | Supplement 22Labeling | Approved | None posted |
| Aug 3, 1984 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| Jul 5, 1983 | Supplement 20Efficacy (new indication or use) | Approved | None posted |
| Jun 14, 1983 | Supplement 19Manufacturing · Priority review | Approved | None posted |
| Apr 13, 1983 | Supplement 17Labeling | Approved | None posted |
| Jan 4, 1983 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| Nov 12, 1982 | Supplement 15Labeling | Approved | None posted |
| Nov 2, 1982 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Sep 8, 1982 | Supplement 13Labeling | Approved | None posted |
| Jun 28, 1982 | Supplement 6Efficacy (new indication or use) | Approved | None posted |
| Jun 23, 1982 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| May 27, 1982 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Feb 19, 1982 | Supplement 9Efficacy (new indication or use) | Approved | None posted |
| Dec 9, 1981 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Oct 8, 1981 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Jan 22, 1981 | Supplement 3Efficacy (new indication or use) | Approved | None posted |
| Jan 25, 1980 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Dec 28, 1979 | Supplement 4Labeling | Approved | None posted |
| Oct 16, 1979 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Oct 1, 1979 | Supplement 1Labeling | Approved | None posted |
| Feb 7, 1979 | Original applicationNew molecular entity · Priority 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
