Neomycin and Polymyxin B Sulfates and Hydrocortisone
Neomycin and Polymyxin B Sulfatesand Hydrocortisone Otic Suspension USP
Approved
Approval ID
595ee3ac-2f33-4459-87ff-be002928059c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 8, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Hydrocortisone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-438
Application NumberANDA064053
Product Classification
M
Marketing Category
C73584
G
Generic Name
Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone
Product Specifications
Route of AdministrationAURICULAR (OTIC)
Effective DateOctober 9, 2008
FDA Product Classification
INGREDIENTS (9)
HYDROCORTISONEActive
Quantity: 10 mg in 1 mL
Code: WI4X0X7BPJ
Classification: ACTIB
NEOMYCIN SULFATEActive
Quantity: 3.5 mg in 1 mL
Code: 057Y626693
Classification: ACTIB
cetyl alcoholInactive
Code: 936JST6JCN
Classification: IACT
POLYMYXIN B SULFATEActive
Quantity: 10000 mg in 1 mL
Code: 19371312D4
Classification: ACTIB
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
sulfuric acidInactive
Code: O40UQP6WCF
Classification: IACT
thimerosalInactive
Code: 2225PI3MOV
Classification: IACT