ANDA 215584, held by Ingenus Pharms Nj. Morphine Sulfate.
As of Nov 15, 2026, ANDA 215584 (Morphine Sulfate), held by Ingenus Pharms Nj, was first approved by FDA on Feb 7, 2022, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 7, 2022 | Original application | Approved |
| Morphine Sulfate15MG · tablet;oral | Morphine Sulfate | Discontinued |
| Morphine Sulfate30MG · tablet;oral | Morphine Sulfate | Discontinued |
| Jun 18, 2026 | Supplement 2REMS | Approved | None posted |
| Oct 31, 2024 | Supplement 1REMS | Approved | None posted |
| Feb 7, 2022 | 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
