ANDA 211086, held by Exela Pharma. Erythromycin Lactobionate.
As of Nov 15, 2026, ANDA 211086 (Erythromycin Lactobionate), held by Exela Pharma, was first approved by FDA on Sep 17, 2020, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 17, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Erythromycin LactobionateEQ 500MG BASE/VIAL ยท injectable;injection | Erythromycin Lactobionate | 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
