Ofloxacin ophthalmic
Ofloxacin Ophthalmic Solution 0_3
Approved
Approval ID
fe564e33-8f5d-4b57-87a9-7afae02eaf97
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 28, 2022
Manufacturers
FDA
Altaire Pharmaceuticals Inc.
DUNS: 786790378
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 Code59390-140
Application NumberANDA202692
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ofloxacin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 31, 2022
FDA Product Classification
INGREDIENTS (5)
OFLOXACINActive
Quantity: 3 mg in 1 mL
Code: A4P49JAZ9H
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT