PREDNISOLONE ACETATE
PREDNISOLONE ACETATEophthalmic suspension, USP 1.0%
Approved
Approval ID
c77597c4-8add-4d2a-b8c1-e526cbe22dcb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2011
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
prednisolone acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-265
Application NumberNDA017011
Product Classification
M
Marketing Category
C73605
G
Generic Name
prednisolone acetate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateNovember 17, 2011
FDA Product Classification
INGREDIENTS (10)
prednisolone acetateActive
Quantity: 10 mg in 1 mL
Code: 8B2807733D
Classification: ACTIB
benzalkonium chlorideInactive
Code: F5UM2KM3W7
Classification: IACT
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
boric acidInactive
Code: R57ZHV85D4
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
sodium bisulfiteInactive
Code: TZX5469Z6I
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium citrateInactive
Code: 1Q73Q2JULR
Classification: IACT