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
NDC Product Code54868-4793
Application NumberNDA050790
Marketing CategoryC73594
Route of AdministrationOPHTHALMIC
Effective DateMay 18, 2011
Generic Namecyclosporine
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