Prednisolone Acetate
Prednisolone Acetate Ophthalmic Suspension USP, 1%
Approved
Approval ID
48d8fd35-51e7-4592-b901-46dd7e8e32b8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 13, 2020
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-0561
Application NumberNDA017469
Product Classification
M
Marketing Category
C73605
G
Generic Name
Prednisolone Acetate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 20, 2016
FDA Product Classification
INGREDIENTS (10)
PREDNISOLONE ACETATEActive
Quantity: 10 mg in 1 mL
Code: 8B2807733D
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT