Cyclosporine
CycloSPORINE Oral Solution USP MODIFIED
Approved
Approval ID
f3dc2a50-1084-4190-a6f3-37034a04db86
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 30, 2015
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
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 Code0172-7313
Application NumberANDA065078
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclosporine
Product Specifications
Route of AdministrationORAL
Effective DateApril 30, 2015
FDA Product Classification
INGREDIENTS (5)
CYCLOSPORINEActive
Quantity: 100 mg in 1 mL
Code: 83HN0GTJ6D
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8F
Classification: IACT
POLYGLYCERYL-3 OLEATEInactive
Code: XRQ165498B
Classification: IACT
POLYGLYCERYL-10 OLEATEInactive
Code: 55C81W76DH
Classification: IACT