Treats corneal cystine crystal deposits. NDA 211302, held by Recordati Rare. Cysteamine Hydrochloride.
As of Nov 14, 2026, NDA 211302 (Cystadrops), held by Recordati Rare, was first approved by FDA on Aug 19, 2020, with 0 approved supplements and 1 published complete response letter.
CYSTADROPS is a cystine-depleting agent indicated for the treatment of corneal cystine crystal deposits in adults and children with cystinosis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 19, 2020 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Jan 28, 2020 | NDA 211302 | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| CystadropsEQ 0.37% BASE · solution/drops;ophthalmic | Cysteamine Hydrochloride | RxReference drug |
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
