RESTASIS
RESTASIS (cyclosporine ophthalmic emulsion) 0.05%
Approved
Approval ID
8227ca35-77c1-4a08-87a3-7dcefef39bc5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 27, 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 Code54868-4793
Application NumberNDA050790
Product Classification
M
Marketing Category
C73594
G
Generic Name
cyclosporine
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMay 18, 2011
FDA Product Classification
INGREDIENTS (7)
CYCLOSPORINEActive
Quantity: 0.5 mg in 1 mL
Code: 83HN0GTJ6D
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CARBOMER COPOLYMER TYPE AInactive
Code: 71DD5V995L
Classification: IACT
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT