Neomycin and Polymyxin B Sulfates and Dexamethasone
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment, USP
Approved
Approval ID
3cd3c3bd-9214-4ded-838d-1bc0ff9adc61
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 26, 2016
Manufacturers
FDA
MWI
DUNS: 019926120
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 Code13985-744
Application NumberANDA064063
Product Classification
M
Marketing Category
C73584
G
Generic Name
Neomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 26, 2016
FDA Product Classification
INGREDIENTS (8)
NEOMYCIN SULFATEActive
Quantity: 3.5 mg in 1 g
Code: 057Y626693
Classification: ACTIM
POLYMYXIN B SULFATEActive
Quantity: 10000 [USP'U] in 1 g
Code: 19371312D4
Classification: ACTIM
DEXAMETHASONEActive
Quantity: 1 mg in 1 g
Code: 7S5I7G3JQL
Classification: ACTIB
LANOLINInactive
Code: 7EV65EAW6H
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT