Application Nr Approved Date Route Status External Links
NDA020392 1994-08-15 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Cystagon® Is Indicated For The Management Of Nephropathic Cystinosis In Children And Adults.

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Ammonia AMMONIA Molecular
2. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
3. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
4. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
5. Gelatin GELATIN Unresolved
6. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
7. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
8. Shellac SHELLAC Unresolved
9. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Cysteamine Bitartrate

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