NDA 19462, held by Bausch. Famotidine.
As of Nov 13, 2026, NDA 19462 (Pepcid), held by Bausch, was first approved by FDA on Oct 15, 1986, with 35 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 6, 2002 | Supplement 30Efficacy (new indication or use) · Standard review | Approved | |
| Dec 10, 1991 | Supplement 10Efficacy (new indication or use) | Approved | None posted |
| Oct 17, 1988 | Supplement 3Efficacy (new indication or use) | Approved | None posted |
| Oct 15, 1986 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pepcid20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Famotidine | DiscontinuedReference drug |
| Pepcid40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Famotidine | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 11, 2018 | Supplement 40Labeling · Standard review | Approved | |
| Jun 21, 2018 | Supplement 39Labeling · Standard review | Approved | |
| Feb 3, 2014 | Supplement 38Labeling · Standard review | Approved | |
| Jun 2, 2011 | Supplement 37Labeling | Approved | |
| Mar 23, 2010 | Supplement 35Labeling | Approved | |
| Nov 5, 2007 | Supplement 34Labeling · Standard review | Approved | |
| Jun 6, 2002 | Supplement 30Efficacy (new indication or use) · Standard review | Approved | |
| Apr 29, 2002 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Apr 25, 2001 | Supplement 29Labeling · Standard review | Approved | |
| Mar 14, 2001 | Supplement 31Labeling · Standard review | Approved | |
| Nov 27, 2000 | Supplement 28Labeling · Standard review | Approved | None posted |
| Mar 18, 1999 | Supplement 27Labeling · Standard review | Approved | |
| Feb 8, 1999 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Nov 25, 1998 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Oct 8, 1998 | Supplement 26Labeling · Standard review | Approved | None posted |
| Aug 12, 1998 | Supplement 22Labeling · Standard review | Approved | None posted |
| Aug 22, 1997 | Supplement 23Labeling · Standard review | Approved | None posted |
| Aug 22, 1997 | Supplement 11Labeling | Approved | None posted |
| Jan 9, 1997 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Nov 13, 1996 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Mar 29, 1996 | Supplement 18Labeling · Standard review | Approved | None posted |
| Mar 29, 1996 | Supplement 16Labeling · Standard review | Approved | None posted |
| Mar 29, 1996 | Supplement 15Labeling · Standard review | Approved | None posted |
| Feb 6, 1996 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Mar 17, 1995 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Dec 10, 1991 | Supplement 10Efficacy (new indication or use) | Approved | None posted |
| Aug 16, 1991 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Nov 30, 1990 | Supplement 12Labeling | Approved | None posted |
| Nov 30, 1990 | Supplement 8Labeling | Approved | None posted |
| Nov 30, 1990 | Supplement 7Labeling | Approved | None posted |
| Nov 23, 1988 | Supplement 5Labeling | Approved | None posted |
| Oct 17, 1988 | Supplement 3Efficacy (new indication or use) | Approved | None posted |
| Aug 18, 1988 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Apr 1, 1987 | Supplement 2Labeling | Approved | None posted |
| Dec 12, 1986 | Supplement 1Labeling | Approved | None posted |
| Oct 15, 1986 | Original applicationNew molecular entity · Standard review | Approved |
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
