Neomycin Polymyxin B Sulfates and Dexamethasone
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension USP (Sterile)
Approved
Approval ID
01e58ae0-cdcf-4c1f-bfb9-9d0fc3ebd002
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 3, 2010
Manufacturers
FDA
MWI/VetOne
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 Code13985-028
Application NumberANDA064135
Product Classification
M
Marketing Category
C73584
G
Generic Name
Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateNovember 14, 2008
FDA Product Classification
INGREDIENTS (10)
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Neomycin SulfateActive
Quantity: 3.5 mg in 1 mL
Code: 057Y626693
Classification: ACTIB
Polymyxin B SulfateActive
Quantity: 10000 [USP'U] in 1 mL
Code: 19371312D4
Classification: ACTIB
DexamethasoneActive
Quantity: 1 mg in 1 mL
Code: 7S5I7G3JQL
Classification: ACTIB
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT