PROCYSBI
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: 1994
Approved
Approval ID
d3a3ec28-f746-463a-bb92-3bc8826db09e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 22, 2022
Manufacturers
FDA
Horizon Therapeutics USA, Inc.
DUNS: 033470838
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cysteamine bitartrate
PRODUCT DETAILS
NDC Product Code75987-100
Application NumberNDA203389
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateFebruary 22, 2022
Generic NameCysteamine bitartrate
INGREDIENTS (1)
CYSTEAMINE BITARTRATEActive
Quantity: 25 mg in 1 1
Code: QO84GZ3TST
Classification: ACTIM
Cysteamine bitartrate
PRODUCT DETAILS
NDC Product Code75987-101
Application NumberNDA203389
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateFebruary 22, 2022
Generic NameCysteamine bitartrate
INGREDIENTS (1)
CYSTEAMINE BITARTRATEActive
Quantity: 75 mg in 1 1
Code: QO84GZ3TST
Classification: ACTIM
Cysteamine bitartrate
PRODUCT DETAILS
NDC Product Code75987-145
Application NumberNDA213491
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateFebruary 22, 2022
Generic NameCysteamine bitartrate
INGREDIENTS (1)
CYSTEAMINE BITARTRATEActive
Quantity: 300 mg in 1 1
Code: QO84GZ3TST
Classification: ACTIM
Cysteamine bitartrate
PRODUCT DETAILS
NDC Product Code75987-140
Application NumberNDA213491
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateFebruary 22, 2022
Generic NameCysteamine bitartrate
INGREDIENTS (1)
CYSTEAMINE BITARTRATEActive
Quantity: 75 mg in 1 1
Code: QO84GZ3TST
Classification: ACTIM