NDA 20902, held by J And J Consumer Inc. Famotidine.
As of Nov 13, 2026, NDA 20902 (Pepcid Ac), held by J And J Consumer Inc, was first approved by FDA on Aug 5, 1999, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 5, 1999 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pepcid Ac10MG · tablet;oral | Famotidine | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 9, 2006 | Supplement 9Labeling · Standard review | Approved | |
| Oct 27, 2004 | Supplement 7Labeling · Standard review | Approved | |
| Jan 31, 2002 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jul 13, 2000 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Aug 5, 1999 | 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
