Cortisporin-TC
Cortisporin-TC Otic Suspension with Neomycin and Hydrocortisone (colistin sulfate—neomycin sulfate—thonzonium bromide—hydrocortisone acetate otic suspension)
Approved
Approval ID
0869fd8d-6dd7-4dc2-b33c-20d72dc47718
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 29, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
colistin sulfate, neomycin sulfate, thonzonium bromide, and hydrocortisone acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-0564
Application NumberNDA050356
Product Classification
M
Marketing Category
C73594
G
Generic Name
colistin sulfate, neomycin sulfate, thonzonium bromide, and hydrocortisone acetate
Product Specifications
Route of AdministrationAURICULAR (OTIC)
Effective DateDecember 30, 2010
FDA Product Classification
INGREDIENTS (7)
COLISTIN SULFATEActive
Quantity: 3 mg in 1 mL
Code: WP15DXU577
Classification: ACTIM
NEOMYCIN SULFATEActive
Quantity: 3.3 mg in 1 mL
Code: 057Y626693
Classification: ACTIM
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
THONZONIUM BROMIDEActive
Quantity: 0.5 mg in 1 mL
Code: JI2B19CR0R
Classification: ACTIM
HYDROCORTISONE ACETATEActive
Quantity: 10 mg in 1 mL
Code: 3X7931PO74
Classification: ACTIM
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT