ANDA 205634, held by Sun Pharm Industries. Morphine Sulfate.
As of Nov 15, 2026, ANDA 205634 (Morphine Sulfate), held by Sun Pharm Industries, was first approved by FDA on Aug 25, 2016, with 5 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 25, 2016 | Original application | Approved |
| Morphine Sulfate15MG · tablet, extended release;oral | Morphine Sulfate | Discontinued |
| Morphine Sulfate30MG · tablet, extended release;oral | Morphine Sulfate | Discontinued |
| Morphine Sulfate60MG · tablet, extended release;oral | Morphine Sulfate | Discontinued |
| Morphine Sulfate100MG · tablet, extended release;oral | Morphine Sulfate | Discontinued |
| Morphine Sulfate200MG · tablet, extended release;oral | Morphine Sulfate | Discontinued |
| Jun 18, 2026 | Supplement 10REMS | Approved | None posted |
| Oct 31, 2024 | Supplement 9REMS | Approved | None posted |
| Sep 18, 2018 | Supplement 5REMS | Approved | None posted |
| May 26, 2017 | Supplement 3REMS | Approved | None posted |
| Sep 30, 2016 | Supplement 1REMS | Approved | None posted |
| Aug 25, 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
