Neomycin and Polymyxin B Sulfates and Dexamethasone
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment
Approved
Approval ID
7f2e3c46-9f39-45e7-99a9-64cc4f6f649d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 31, 2021
Manufacturers
FDA
Sandoz Inc
DUNS: 005387188
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
NDC Product Code61314-631
Application NumberNDA050065
Marketing CategoryC73605
Route of AdministrationOPHTHALMIC
Effective DateJuly 20, 2011
Generic NameNeomycin and Polymyxin B Sulfates and Dexamethasone
INGREDIENTS (7)
POLYMYXIN B SULFATEActive
Quantity: 10000 [iU] in 1 g
Code: 19371312D4
Classification: ACTIM
DEXAMETHASONEActive
Quantity: 1 mg in 1 g
Code: 7S5I7G3JQL
Classification: ACTIB
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
NEOMYCIN SULFATEActive
Quantity: 3.5 mg in 1 g
Code: 057Y626693
Classification: ACTIM
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
LANOLINInactive
Code: 7EV65EAW6H
Classification: IACT