ANDA 75295, held by Strides Pharma Intl. Morphine Sulfate.
As of Nov 15, 2026, ANDA 75295 (Morphine Sulfate), held by Strides Pharma Intl, was first approved by FDA on Oct 28, 1998, with 26 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 28, 1998 | 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 59REMS | Approved | None posted |
| Oct 31, 2024 | Supplement 57REMS | Approved | None posted |
| Sep 18, 2018 | Supplement 51REMS | Approved | None posted |
| May 26, 2017 | Supplement 48REMS | Approved | None posted |
| Sep 30, 2016 | Supplement 47REMS | Approved | None posted |
| Apr 20, 2016 | Supplement 44REMS | Approved | None posted |
| Jun 26, 2015 | Supplement 41REMS | Approved | None posted |
| Aug 19, 2014 | Supplement 38REMS | Approved | None posted |
| Aug 11, 2014 | Supplement 35Labeling · Standard review | Approved | None posted |
| Aug 28, 2013 | Supplement 32REMS | Approved | None posted |
| Jul 9, 2012 | Supplement 30Labeling | Approved | None posted |
| Jul 9, 2012 | Supplement 28REMS | Approved | None posted |
| Dec 20, 2010 | Supplement 26Labeling | Approved | None posted |
| Jul 2, 2010 | Supplement 24Labeling | Approved | None posted |
| Nov 6, 2002 | Supplement 14Manufacturing | Approved | None posted |
| Nov 6, 2002 | Supplement 13Manufacturing | Approved | None posted |
| Nov 26, 2001 | Supplement 12Manufacturing | Approved | None posted |
| Aug 15, 2001 | Supplement 11Manufacturing | Approved | None posted |
| Jan 25, 2001 | Supplement 10Manufacturing | Approved | None posted |
| Sep 15, 2000 | Supplement 9Labeling | Approved | None posted |
| Sep 15, 2000 | Supplement 8Manufacturing | Approved | None posted |
| Sep 15, 2000 | Supplement 7Manufacturing | Approved | None posted |
| Sep 15, 2000 | Supplement 6Labeling | Approved | None posted |
| Sep 15, 2000 | Supplement 5Manufacturing | Approved | None posted |
| Nov 3, 1999 | Supplement 4Manufacturing | Approved | None posted |
| Aug 12, 1999 | Supplement 3Manufacturing | Approved | None posted |
| Oct 28, 1998 | 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
