NDA 18703, held by Glaxo Grp Ltd. Ranitidine Hydrochloride.
As of Nov 14, 2026, NDA 18703 (Zantac 150, Zantac 300), held by Glaxo Grp Ltd, was first approved by FDA on Jun 9, 1983, with 61 approved supplements and 0 published complete response letters.
| Oct 29, 1999 | Supplement 56Efficacy (new indication or use) · Standard review | Approved | |
| Mar 29, 1995 | Supplement 50Efficacy (new indication or use) · Standard review | Approved | None posted |
| Nov 3, 1994 | Supplement 47Efficacy (new indication or use) | Approved | None posted |
| Feb 28, 1994 | Supplement 46Efficacy (new indication or use) | Approved | None posted |
| May 19, 1992 | Supplement 42Efficacy (new indication or use) | Approved | None posted |
| May 30, 1986 | Supplement 8Efficacy (new indication or use) | Approved | None posted |
| May 30, 1986 | Supplement 4Efficacy (new indication or use) | Approved | None posted |
| Dec 9, 1985 | Supplement 6Efficacy (new indication or use) | Approved | None posted |
| Jun 28, 1985 | Supplement 2Efficacy (new indication or use) | Approved | None posted |
| Jun 9, 1983 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Zantac 150EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Ranitidine Hydrochloride | DiscontinuedReference drug |
| Zantac 300EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Ranitidine Hydrochloride | DiscontinuedReference drug |
| Sep 4, 2009 | Supplement 68Labeling · Standard review | Approved | |
| Feb 20, 2009 | Supplement 67Labeling · Standard review | Approved | |
| Jul 12, 2006 | Supplement 66Labeling · Standard review | Approved | |
| Apr 28, 2005 | Supplement 65Labeling · Standard review | Approved | |
| Jan 15, 2002 | Supplement 62Manufacturing · Standard review | Approved | None posted |
| Jan 7, 2002 | Supplement 61Labeling · Standard review | Approved | |
| May 9, 2001 | Supplement 60Labeling · Standard review | Approved | None posted |
| Oct 29, 1999 | Supplement 56Efficacy (new indication or use) · Standard review | Approved | |
| Oct 29, 1999 | Supplement 59Labeling · Standard review | Approved | None posted |
| Oct 22, 1999 | Supplement 57Labeling · Standard review | Approved | None posted |
| Oct 22, 1999 | Supplement 58Labeling · Standard review | Approved | None posted |
| Nov 27, 1996 | Supplement 55Labeling · Standard review | Approved | None posted |
| Jan 26, 1996 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Mar 29, 1995 | Supplement 50Efficacy (new indication or use) · Standard review | Approved | None posted |
| Nov 3, 1994 | Supplement 47Efficacy (new indication or use) | Approved | None posted |
| Nov 3, 1994 | Supplement 53Labeling · Standard review | Approved | None posted |
| Oct 19, 1994 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| Feb 28, 1994 | Supplement 46Efficacy (new indication or use) | Approved | None posted |
| Jun 3, 1993 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Apr 5, 1993 | Supplement 48Labeling | Approved | None posted |
| Jul 22, 1992 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Jul 2, 1992 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| May 19, 1992 | Supplement 42Efficacy (new indication or use) | Approved | None posted |
| Nov 25, 1991 | Supplement 36Labeling | Approved | None posted |
| Jan 4, 1991 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Jan 4, 1991 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Dec 20, 1990 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Dec 12, 1990 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Nov 21, 1990 | Supplement 40Labeling | Approved | None posted |
| Jul 16, 1990 | Supplement 37Labeling | Approved | None posted |
| Feb 6, 1990 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1989 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| May 18, 1989 | Supplement 33Labeling | Approved | None posted |
| Feb 3, 1989 | Supplement 29Labeling | Approved | None posted |
| Oct 25, 1988 | Supplement 30Labeling | Approved | None posted |
| Sep 30, 1988 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Sep 29, 1988 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| May 20, 1988 | Supplement 26Labeling | Approved | None posted |
| May 20, 1988 | Supplement 25Labeling | Approved | None posted |
| Oct 29, 1987 | Supplement 24Labeling | Approved | None posted |
| Aug 27, 1987 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Apr 24, 1987 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Mar 6, 1987 | Supplement 20Labeling | Approved | None posted |
| Oct 27, 1986 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Oct 27, 1986 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1986 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| May 30, 1986 | Supplement 8Efficacy (new indication or use) | Approved | None posted |
| May 30, 1986 | Supplement 4Efficacy (new indication or use) | Approved | None posted |
| Feb 20, 1986 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Dec 9, 1985 | Supplement 16Labeling | Approved | None posted |
| Dec 9, 1985 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Dec 9, 1985 | Supplement 6Efficacy (new indication or use) | Approved | None posted |
| Nov 20, 1985 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Aug 23, 1985 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jun 28, 1985 | Supplement 2Efficacy (new indication or use) | Approved | None posted |
| Feb 22, 1985 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Feb 4, 1985 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Sep 13, 1984 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1984 | Supplement 5Labeling | Approved | None posted |
| Feb 28, 1984 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jan 5, 1984 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jun 9, 1983 | Original applicationNew molecular entity · 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
