ANDA 201574, held by Padagis US. Morphine Sulfate.
As of Nov 15, 2026, ANDA 201574 (Morphine Sulfate), held by Padagis US, was first approved by FDA on Aug 6, 2012, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 6, 2012 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Morphine Sulfate100MG/5ML ยท solution;oral | Morphine Sulfate | Discontinued |
| Jun 18, 2026 | Supplement 11REMS | Approved | None posted |
| Oct 31, 2024 | Supplement 9REMS | Approved | None posted |
| Sep 18, 2018 | Supplement 3REMS | Approved | None posted |
| Aug 6, 2012 | 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
