NDA 21712, held by Ucb Inc. Famotidine.
As of Nov 14, 2026, NDA 21712 (Fluxid), held by Ucb Inc, was first approved by FDA on Sep 24, 2004, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 24, 2004 | Original applicationNew dosage form · Standard review | Approved |
| Fluxid20MG · tablet, orally disintegrating;oral | Famotidine | Discontinued |
| Fluxid40MG · tablet, orally disintegrating;oral | Famotidine | Discontinued |
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
