FDA.reportPublic FDA data

CYSTEAMINE Pharmacologic Class Indexing

Class set ID
948c4879-1123-4f8c-82dc-9dd64bdbbb33
Version
3
Effective date
20180813
Type
Indexing - Pharmacologic Class

Mapped DailyMed Labels#

Label, Manufacturer, Effective table
LabelManufacturerEffectiveSPL version
These highlights do not include all the information needed to use CYSTADROPS safely and effectively. See full prescribing information for CYSTADROPS . CYSTADROPS ® (cysteamine ophthalmic solution) 0.37%, for topical ophthalmic use Initial U.S. Approval: 1994RECORDATI RARE DISEASES, INC. | Baccinex SA202506065
These highlights do not include all the information needed to use CYSTARAN ® safely and effectively. See full prescribing information for CYSTARAN. CYSTARAN (cysteamine ophthalmic solution) 0.44%, for topical ophthalmic use Initial U.S. Approval: 1994Leadiant Biosciences, Inc.2025043023
These highlights do not include all the information needed to use PROCYSBI safely and effectively. See Full Prescribing Information for PROCYSBI. PROCYSBI ® (cysteamine bitartrate) delayed-release capsules, for oral use PROCYSBI ® (cysteamine bitartrate) delayed-release oral granules Initial U.S. Approval: 1994Horizon Therapeutics USA, Inc.2025040912
f495b76d-96c6-48e5-8fa3-30a4336628ebMylan Pharmaceuticals Inc.2021081613