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Neomycin and Polymyxin B Sulfates and Dexamethasone

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment

Approved
Approval ID

aa7b8a3f-06dd-4190-96a5-f86195bd2197

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 1, 2021

Manufacturers
FDA

Proficient Rx LP

DUNS: 079196022

Products 1

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

Neomycin and Polymyxin B Sulfates and Dexamethasone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71205-330
Application NumberNDA050065
Product Classification
M
Marketing Category
C73605
G
Generic Name
Neomycin and Polymyxin B Sulfates and Dexamethasone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 1, 2021
FDA Product Classification

INGREDIENTS (7)

DEXAMETHASONEActive
Quantity: 1 mg in 1 g
Code: 7S5I7G3JQL
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
LANOLINInactive
Code: 7EV65EAW6H
Classification: IACT
POLYMYXIN B SULFATEActive
Quantity: 10000 [iU] in 1 g
Code: 19371312D4
Classification: ACTIM
NEOMYCIN SULFATEActive
Quantity: 3.5 mg in 1 g
Code: 057Y626693
Classification: ACTIM
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT

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