Ofloxacin
Ofloxacin Otic Solution
Approved
Approval ID
75d8099b-4e08-43c0-811e-589d4fb52932
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 13, 2011
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.
Ofloxaxin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-881
Application NumberANDA076616
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ofloxaxin
Product Specifications
Route of AdministrationAURICULAR (OTIC)
Effective DateOctober 26, 2009
FDA Product Classification
INGREDIENTS (6)
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
OFLOXACINActive
Quantity: 3 mg in 1 mL
Code: A4P49JAZ9H
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT