Ofloxacin
Ofloxacin Ophthalmic Solution 0.3% (Sterile)
Approved
Approval ID
7bfa54ff-9a72-45e1-8fe5-e8411f8c6e71
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 22, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-439
Application NumberANDA076622
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ofloxacin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMay 26, 2010
FDA Product Classification
INGREDIENTS (6)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
OFLOXACINActive
Quantity: 3 mg in 1 mL
Code: A4P49JAZ9H
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT