Cyclosporine
Cyclosporine Injection, USP
Approved
Approval ID
5977b562-3624-427c-bc64-b07247751b9e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2023
Manufacturers
FDA
Padagis US LLC
DUNS: 967694121
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cyclosporine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0574-0866
Application NumberANDA065151
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclosporine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 1, 2023
FDA Product Classification
INGREDIENTS (4)
CYCLOSPORINEActive
Quantity: 50 mg in 1 mL
Code: 83HN0GTJ6D
Classification: ACTIB
POLYOXYL 35 CASTOR OILInactive
Code: 6D4M1DAL6O
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT