NDA 21604, held by Moberg Pharma North. Ibuprofen.
As of Nov 14, 2026, NDA 21604 (Children'S Elixsure), held by Moberg Pharma North, was first approved by FDA on Jan 7, 2004, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 7, 2004 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Children'S Elixsure100MG/5ML · suspension;oral | Ibuprofen | Discontinued |
| Mar 15, 2017 | Supplement 5Labeling · Standard review | Approved | |
| Mar 31, 2014 | Supplement 4Labeling · Standard review | Approved | |
| Jan 17, 2006 | Supplement 3Labeling · Standard review | Approved | |
| Jan 7, 2004 | Original applicationNew formulation or manufacturer · 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
