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NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE

Approved
Approval ID

4aecebf1-2f64-725d-e054-00144ff8d46c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 21, 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.

neomycin, polymyxin b sulfates, dexamethasone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code61919-113
Application NumberANDA062938
Product Classification
M
Marketing Category
C73584
G
Generic Name
neomycin, polymyxin b sulfates, dexamethasone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 21, 2020
FDA Product Classification

INGREDIENTS (5)

NEOMYCIN SULFATEActive
Quantity: 3.5 mg in 1 g
Code: 057Y626693
Classification: ACTIM
DEXAMETHASONEActive
Quantity: 1 mg in 1 g
Code: 7S5I7G3JQL
Classification: ACTIB
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
POLYMYXIN B SULFATEActive
Quantity: 10000 [USP'U] in 1 g
Code: 19371312D4
Classification: ACTIM
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT

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NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE - FDA Drug Approval Details