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Maxitrol

MAXITROL- neomycin sulfate, polymyxin b sulfate and dexamethasone suspension

Approved
Approval ID

ecfb954f-5554-0ad2-e053-2995a90a7516

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 13, 2023

Manufacturers
FDA

Harrow Eye, LLC

DUNS: 118526951

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

neomycin sulfate, polymyxin b sulfate and dexamethasone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code82667-100
Application NumberNDA050023
Product Classification
M
Marketing Category
C73594
G
Generic Name
neomycin sulfate, polymyxin b sulfate and dexamethasone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateDecember 13, 2023
FDA Product Classification

INGREDIENTS (10)

BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
HYPROMELLOSE 2910 (4000 MPA.S)Inactive
Code: RN3152OP35
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
NEOMYCIN SULFATEActive
Quantity: 3.5 mg in 1 mL
Code: 057Y626693
Classification: ACTIM
POLYMYXIN B SULFATEActive
Quantity: 10000 [USP'U] in 1 mL
Code: 19371312D4
Classification: ACTIM
DEXAMETHASONEActive
Quantity: 1 mg in 1 mL
Code: 7S5I7G3JQL
Classification: ACTIB

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Maxitrol - FDA Drug Approval Details