Application Nr Approved Date Route Status External Links
NDA203389 2013-04-30 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Procysbi Is Indicated For The Treatment Of Nephropathic Cystinosis In Adult And Pediatric Patients 2 Years Of Age And Older. Procysbi Is A Cystine-Depleting Agent Indicated For The Treatment Of Nephropathic Cystinosis In Adult And Pediatric Patients 2 Years Of Age And Older. (1)

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
2. Hypromelloses HYPROMELLOSES Unresolved
3. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
4. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
5. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Cysteamine Bitartrate

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