ANDA 86754, held by Abraxis Pharm. Mannitol.
As of Nov 13, 2026, ANDA 86754 (Mannitol 25%), held by Abraxis Pharm, was first approved by FDA on Jun 10, 1980, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 10, 1980 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mannitol 25%12.5GM/50ML ยท injectable;injection | Mannitol | Discontinued |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
