NDA 21472, held by Bionpharma. Ibuprofen.
As of Nov 14, 2026, NDA 21472 (Midol Liquid Gels), held by Bionpharma, was first approved by FDA on Oct 18, 2002, with 9 approved supplements and 0 published complete response letters.
| Mar 13, 2006 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Oct 18, 2002 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Midol Liquid Gels200MG · capsule;oral | Ibuprofen | OTCReference drug |
| Oct 21, 2021 | Supplement 15Labeling · Standard review | Approved | |
| Mar 16, 2017 | Supplement 14Labeling · Standard review | Approved | |
| Apr 28, 2010 | Supplement 13Labeling | Approved | |
| Apr 15, 2009 | Supplement 12Labeling · Standard review | Approved | |
| Feb 19, 2009 | Supplement 11Labeling · Standard review | Approved | |
| Dec 18, 2006 | Supplement 7Labeling · Standard review | Approved | |
| Mar 13, 2006 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Dec 21, 2005 | Supplement 6Labeling · Standard review | Approved | |
| Jan 22, 2004 | Supplement 1Labeling · Standard review | Approved | |
| Oct 18, 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
