OFLOXACIN OTIC
OFLAXACIN OTIC
Approved
Approval ID
a7952956-b64a-0f99-e053-2995a90a0f91
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 11, 2020
Manufacturers
FDA
DIRECT RX
DUNS: 079254320
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 Code72189-108
Application NumberANDA076527
Product Classification
M
Marketing Category
C73584
G
Generic Name
OFLOXACIN
Product Specifications
Route of AdministrationAURICULAR (OTIC)
Effective DateJune 11, 2020
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
OFLOXACINActive
Quantity: 3 mg in 1 mL
Code: A4P49JAZ9H
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT