ofloxacin
Ofloxacin Ophthalmic Solution USP 0.3%
Approved
Approval ID
557b44ee-bea9-4dfe-866b-f0e3d8fcd018
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 8, 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.
ofloxacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-763
Application NumberANDA078559
Product Classification
M
Marketing Category
C73584
G
Generic Name
ofloxacin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateSeptember 8, 2011
FDA Product Classification
INGREDIENTS (5)
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
ofloxacinActive
Quantity: 3 mg in 1 mL
Code: A4P49JAZ9H
Classification: ACTIB
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
benzalkonium chlorideInactive
Quantity: 0.05 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT