Neomycin and Polymyxin B Sulfates and Dexamethasone
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment USP STERILE Rx Only
Approved
Approval ID
d92683cc-b6e0-4e52-aefa-990f3369b4dc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2019
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-0571
Application NumberANDA062938
Product Classification
M
Marketing Category
C73584
G
Generic Name
Neomycin, Polymyxin B Sulfates, Dexamethasone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMarch 1, 2018
FDA Product Classification
INGREDIENTS (5)
DEXAMETHASONEActive
Quantity: 1 mg in 1 g
Code: 7S5I7G3JQL
Classification: ACTIB
POLYMYXIN B SULFATEActive
Quantity: 10000 [USP'U] in 1 g
Code: 19371312D4
Classification: ACTIM
NEOMYCIN SULFATEActive
Quantity: 3.5 mg in 1 g
Code: 057Y626693
Classification: ACTIM
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT