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Neomycin and Polymyxin B Sulfates and Dexamethasone

Sterile

Approved
Approval ID

7b18587e-2d50-453c-8521-fb0c4fe51611

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 14, 2018

Manufacturers
FDA

Aidarex Pharmaceuticals LLC

DUNS: 801503249

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 Code33261-551
Application NumberANDA062341
Product Classification
M
Marketing Category
C73584
G
Generic Name
neomycin sulfate, polymyxin b sulfate and dexamethasone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateAugust 14, 2018
FDA Product Classification

INGREDIENTS (10)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
NEOMYCIN SULFATEActive
Quantity: 3.5 mg in 1 mL
Code: 057Y626693
Classification: ACTIM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
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
HYPROMELLOSE 2910 (4000 MPA.S)Inactive
Code: RN3152OP35
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT

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Neomycin and Polymyxin B Sulfates and Dexamethasone - FDA Drug Approval Details