Cyclosporine
CycloSPORINE Capsules USP MODIFIED (Soft Gelatin Capsules)
Approved
Approval ID
2de1e8b1-625f-43ce-a1d5-d543be208b11
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 8, 2021
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
Products 3
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 Code0093-9020
Application NumberANDA065110
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclosporine
Product Specifications
Route of AdministrationORAL
Effective DateJune 8, 2021
FDA Product Classification
INGREDIENTS (12)
GLYCINEInactive
Code: TE7660XO1C
Classification: IACT
CYCLOSPORINEActive
Quantity: 100 mg in 1 1
Code: 83HN0GTJ6D
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
.ALPHA.-TOCOPHEROL, DL-Inactive
Code: 7QWA1RIO01
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
GLYCERYL MONOLINOLEATEInactive
Code: 4763AXI84L
Classification: IACT
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8F
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
NONCRYSTALLIZING SORBITOL SOLUTIONInactive
Code: 9E0S3UM200
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
BROWN IRON OXIDEInactive
Code: 1N032N7MFO
Classification: IACT
Cyclosporine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-9018
Application NumberANDA065110
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclosporine
Product Specifications
Route of AdministrationORAL
Effective DateJune 8, 2021
FDA Product Classification
INGREDIENTS (12)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
CYCLOSPORINEActive
Quantity: 25 mg in 1 1
Code: 83HN0GTJ6D
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
.ALPHA.-TOCOPHEROL, DL-Inactive
Code: 7QWA1RIO01
Classification: IACT
GLYCINEInactive
Code: TE7660XO1C
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
GLYCERYL MONOLINOLEATEInactive
Code: 4763AXI84L
Classification: IACT
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8F
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
NONCRYSTALLIZING SORBITOL SOLUTIONInactive
Code: 9E0S3UM200
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Cyclosporine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-9019
Application NumberANDA065110
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclosporine
Product Specifications
Route of AdministrationORAL
Effective DateJune 8, 2021
FDA Product Classification
INGREDIENTS (12)
.ALPHA.-TOCOPHEROL, DL-Inactive
Code: 7QWA1RIO01
Classification: IACT
CYCLOSPORINEActive
Quantity: 50 mg in 1 1
Code: 83HN0GTJ6D
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCINEInactive
Code: TE7660XO1C
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GLYCERYL MONOLINOLEATEInactive
Code: 4763AXI84L
Classification: IACT
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8F
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
NONCRYSTALLIZING SORBITOL SOLUTIONInactive
Code: 9E0S3UM200
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT