Cyclosporine
CYCLOSPORINE CAPSULES USP MODIFIED (Soft Gelatin Capsules)Rx only
Approved
Approval ID
893508f4-d20a-4511-94bb-b8f120734904
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 31, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-6232
Application NumberANDA065110
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclosporine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 4, 2011
FDA Product Classification
INGREDIENTS (9)
CyclosporineActive
Quantity: 100 mg in 1 1
Code: 83HN0GTJ6D
Classification: ACTIB
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
GLYCINEInactive
Code: TE7660XO1C
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8F
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
.ALPHA.-TOCOPHEROL, DL-Inactive
Code: 7QWA1RIO01
Classification: IACT