NDA 210910, held by Cosmo Technologies. Rifamycin Sodium.
As of Nov 13, 2026, NDA 210910 (Aemcolo), held by Cosmo Technologies, was first approved by FDA on Nov 16, 2018, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 16, 2018 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| AemcoloEQ 194MG BASE · tablet, delayed release;oral | Rifamycin Sodium | DiscontinuedReference drug |
| Jul 12, 2019 | Supplement 1Labeling · Standard review | Approved | |
| Nov 16, 2018 | Original applicationNew molecular entity · Priority 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
