Cystagon
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Approved
Approval ID
f495b76d-96c6-48e5-8fa3-30a4336628eb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 16, 2021
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
cysteamine bitartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-9045
Application NumberNDA020392
Product Classification
M
Marketing Category
C73594
G
Generic Name
cysteamine bitartrate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 16, 2021
FDA Product Classification
INGREDIENTS (13)
CYSTEAMINE BITARTRATEActive
Quantity: 150 mg in 1 1
Code: QO84GZ3TST
Classification: ACTIM
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 112Inactive
Code: X7XJ6RM9Q2
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
cysteamine bitartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-9040
Application NumberNDA020392
Product Classification
M
Marketing Category
C73594
G
Generic Name
cysteamine bitartrate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 16, 2021
FDA Product Classification
INGREDIENTS (13)
CYSTEAMINE BITARTRATEActive
Quantity: 50 mg in 1 1
Code: QO84GZ3TST
Classification: ACTIM
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 112Inactive
Code: X7XJ6RM9Q2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT