Ofloxacin
Ofloxacin Ophthalmic Solution, 0.3% Sterile
Approved
Approval ID
1cb71324-72e7-40f8-8c51-25c7aa0bce57
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 3, 2010
Manufacturers
FDA
Keltman Pharmaceuticals Inc.
DUNS: 362861077
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 Code68387-106
Application NumberANDA076615
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ofloxacin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateAugust 3, 2010
FDA Product Classification
INGREDIENTS (6)
OFLOXACINActive
Quantity: 3 mg in 1 mL
Code: A4P49JAZ9H
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT