Manages nephropathic cystinosis. NDA 20392, held by Mylan. Cysteamine Bitartrate.
As of Nov 14, 2026, NDA 20392 (Cystagon), held by Mylan, was first approved by FDA on Aug 15, 1994, with 9 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE CYSTAGON is indicated for the management of nephropathic cystinosis in children and adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 15, 1994 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| CystagonEQ 50MG BASE · capsule;oral | Cysteamine Bitartrate | RxReference drug |
| CystagonEQ 150MG BASE · capsule;oral | Cysteamine Bitartrate | RxReference drug |
| Jun 6, 2016 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Jun 15, 2015 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| Jun 6, 2007 | Supplement 10Labeling · Standard review | Approved | |
| Jan 30, 2004 | Supplement 7Labeling · Standard review | Approved | |
| Apr 6, 2001 | Supplement 5Labeling · Standard review | Approved | |
| Mar 5, 1999 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Feb 12, 1998 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Aug 16, 1996 | Supplement 2Labeling · Standard review | Approved | None posted |
| Nov 28, 1995 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Aug 15, 1994 | Original applicationNew molecular entity · Priority review | Approved | None posted |
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
