NDA 21799, held by Sun Pharm Industries. Quinine Sulfate.
As of Nov 14, 2026, NDA 21799 (Qualaquin), held by Sun Pharm Industries, was first approved by FDA on Aug 12, 2005, with 13 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 12, 2005 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Qualaquin324MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Quinine Sulfate | DiscontinuedReference drug |
| Jun 19, 2019 | Supplement 29Labeling · Standard review | Approved | |
| Jul 2, 2014 | Supplement 24Labeling · Standard review | Approved | |
| Apr 13, 2013 | Supplement 23Labeling · Standard review | Approved | |
| Feb 22, 2013 | Supplement 21Labeling · Standard review | Approved | |
| May 22, 2012 | Supplement 20REMS | Approved | None posted |
| May 22, 2012 | Supplement 22Labeling · Standard review | Approved | |
| Apr 14, 2011 | Supplement 16Labeling · Standard review | Approved | |
| Jun 15, 2010 | Supplement 11Labeling · Standard review | Approved | |
| Jan 22, 2010 | Supplement 15Labeling | Approved | |
| Dec 23, 2009 | Supplement 13Labeling · Standard review | Approved | |
| Nov 20, 2009 | Supplement 14Labeling | Approved | |
| Nov 14, 2008 | Supplement 8Labeling · Standard review | Approved | |
| Oct 3, 2007 | Supplement 6Labeling · Standard review | Approved | |
| Aug 12, 2005 | 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
