Ofloxacin
Ofloxacin Ophthalmic solution USP 0.3%
Approved
Approval ID
b4d09b4d-bc6a-405b-91c8-e4246336a1f7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 21, 2017
Manufacturers
FDA
FDC Limited
DUNS: 650441301
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 Code55545-1003
Application NumberANDA078559
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ofloxacin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateNovember 21, 2017
FDA Product Classification
INGREDIENTS (5)
OFLOXACINActive
Quantity: 3 mg in 1 mL
Code: A4P49JAZ9H
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Quantity: 0.05 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT