NDA 219457, held by Fresenius Medical Care Renal Therapies Group LLC. Multibic.
As of Nov 13, 2026, NDA 219457 (Multibic), held by Fresenius Medical Care Renal Therapies Group LLC, was first approved by FDA on Nov 9, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 9, 2026 | Original applicationNew active ingredient · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| MultibicN/A · solution | Multibic | Rx |
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
