ANDA 213892, held by Quagen. Morphine Sulfate.
As of Nov 15, 2026, ANDA 213892 (Morphine Sulfate), held by Quagen, was first approved by FDA on Jul 7, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 7, 2026 | Original application | Approved | None posted |
| Morphine Sulfate10MG/5ML · solution;oral | Morphine Sulfate | Rx |
| Morphine Sulfate20MG/5ML · solution;oral | Morphine Sulfate | Rx |
| Morphine Sulfate100MG/5ML · solution;oral | Morphine Sulfate | Rx |
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
