NDA 21260, held by King Pharms LLC. Morphine Sulfate.
As of Nov 15, 2026, NDA 21260 (Avinza), held by King Pharms LLC, was first approved by FDA on Mar 20, 2002, with 10 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 20, 2002 | Original applicationNew dosage form · Standard review | Approved |
| Avinza30MG · capsule, extended release;oral | Morphine Sulfate | Discontinued |
| Avinza60MG · capsule, extended release;oral | Morphine Sulfate | Discontinued |
| Avinza90MG · capsule, extended release;oral | Morphine Sulfate | Discontinued |
| Avinza120MG · capsule, extended release;oral | Morphine Sulfate | Discontinued |
| Avinza45MG · capsule, extended release;oral | Morphine Sulfate | Discontinued |
| Avinza75MG · capsule, extended release;oral | Morphine Sulfate | Discontinued |
| Jun 26, 2015 | Supplement 24 | Approved | |
| Aug 19, 2014 | Supplement 23 | Approved | |
| Apr 16, 2014 | Supplement 22Labeling · Standard review | Approved | |
| May 6, 2013 | Supplement 17Labeling · Standard review | Approved | |
| Apr 15, 2013 | Supplement 18Labeling · Standard review | Approved | |
| Jul 9, 2012 | Supplement 15Labeling · Standard review | Approved | |
| Jul 9, 2012 | Supplement 16Labeling · Standard review | Approved | |
| Dec 18, 2008 | Supplement 13Manufacturing · Standard review | Approved | |
| Oct 18, 2005 | Supplement 6Labeling · Standard review | Approved | |
| Nov 8, 2002 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Mar 20, 2002 | Original applicationNew dosage form · Standard review | 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
