NDA 20801, held by Kenvue Brands. Famotidine.
As of Nov 13, 2026, NDA 20801 (Pepcid Ac), held by Kenvue Brands, was first approved by FDA on Sep 24, 1998, with 11 approved supplements and 0 published complete response letters.
| Dec 17, 2007 | Supplement 12Efficacy (new indication or use) | Approved | |
| Sep 24, 1998 | Original applicationNew dosage form · Standard review | Approved |
| Pepcid Ac10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, chewable;oral | Famotidine | DiscontinuedReference drug |
| Pepcid Ac20MG · tablet, chewable;oral | Famotidine | OTCReference drug |
| Oct 29, 2019 | Supplement 20Labeling · Standard review | Approved | |
| Mar 20, 2014 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Sep 11, 2013 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Apr 1, 2013 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Dec 17, 2007 | Supplement 12Efficacy (new indication or use) | Approved | |
| Oct 27, 2004 | Supplement 10Labeling · Standard review | Approved | |
| Jan 31, 2002 | Supplement 7Labeling · Standard review | Approved | |
| Mar 29, 2001 | Supplement 4Manufacturing · Standard review | Approved | |
| Apr 26, 2000 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Apr 6, 2000 | Supplement 2Labeling · Standard review | Approved | None posted |
| Aug 20, 1999 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Sep 24, 1998 | Original applicationNew dosage form · 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
