ANDA 206420, held by Rhodes Pharms. Morphine Sulfate.
As of Nov 15, 2026, ANDA 206420 (Morphine Sulfate), held by Rhodes Pharms, was first approved by FDA on Jul 12, 2016, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 12, 2016 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Morphine Sulfate20MG/5ML ยท solution;oral | Morphine Sulfate | Discontinued |
| Jun 18, 2026 | Supplement 4REMS | Approved | None posted |
| Sep 18, 2018 | Supplement 1REMS | Approved | None posted |
| Jul 12, 2016 | Original application | 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
