Ofloxacin Otic
Ofloxacin Otic Solution 0.3%
Approved
Approval ID
7592cf3f-7d4b-436f-89f0-a3686570fef8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 7, 2023
Manufacturers
FDA
RPK Pharmaceuticals, Inc.
DUNS: 147096275
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 Code53002-2604
Application NumberANDA076527
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ofloxacin
Product Specifications
Route of AdministrationAURICULAR (OTIC)
Effective DateNovember 17, 2022
FDA Product Classification
INGREDIENTS (6)
OFLOXACINActive
Quantity: 3 mg in 1 mL
Code: A4P49JAZ9H
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT