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
NDC Product Code0378-9045
Application NumberNDA020392
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateAugust 16, 2021
Generic Namecysteamine bitartrate
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
NDC Product Code0378-9040
Application NumberNDA020392
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateAugust 16, 2021
Generic Namecysteamine bitartrate
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