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