Active ingredient
Cysteamine
9 finished FDA listings contain Cysteamine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- CYSTEAMINE BITARTRATE, CYSTEAMINE HYDROCHLORIDE
- Dosage forms
- Capsule, Capsule, Delayed Release Pellets, Granule, Delayed Release, Solution
- Routes
- Ophthalmic, Oral
- Manufacturers / labelers
- 4
- Strengths listed
- 150 mg/1 · 25 mg/1 · 3.5 mg/ml · 300 mg/1 · 50 mg/1 · 6.5 mg/ml · 75 mg/1
- Brand names in FDA listings
- Cystadrops, Cystagon, Cystaran, Procysbi
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 3022
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 020392 | MYLAN | 1994-08-15 | 2 |
| NDA 200740 | LEADIANT BIOSCI INC | 2012-10-02 | 2 |
| NDA 203389 | HORIZON | 2013-04-30 | 2 |
| NDA 213491 | HORIZON | 2020-02-14 | 2 |
| NDA 211302 | RECORDATI RARE | 2020-08-19 | 1 |
Official labeling on DailyMed
- PROCYSBI (CYSTEAMINE BITARTRATE) CAPSULE, DELAYED RELEASE PELLETS PROCYSBI (CYSTEAMINE BITARTRATE) GRANULE, DELAYED RELEASE [HORIZON THERAPEUTICS USA, INC.] · version 13 · 2026-06-30
- CYSTADROPS (CYSTEAMINE HYDROCHLORIDE) SOLUTION [RECORDATI RARE DISEASES, INC.] · version 5 · 2025-06-13
- CYSTARAN (CYSTEAMINE HYDROCHLORIDE) SOLUTION [LEADIANT BIOSCIENCES, INC.] · version 23 · 2025-05-05
- CYSTAGON (CYSTEAMINE BITARTRATE) CAPSULE [MYLAN PHARMACEUTICALS INC.] · version 13 · 2024-12-16
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.