Cortisporin TC
(colistin sulfate—neomycin sulfate—thonzonium bromide—hydrocortisone acetate otic suspension)
Approved
Approval ID
9c6fc1c7-3350-42ae-b999-aca48e704bb1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 15, 2019
Manufacturers
FDA
Endo Pharmaceuticals, Inc.
DUNS: 178074951
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 Code63481-529
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 DateApril 30, 2019
FDA Product Classification
INGREDIENTS (8)
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
THIMEROSALInactive
Code: 2225PI3MOV
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
THONZONIUM BROMIDEActive
Quantity: 0.5 mg in 1 mL
Code: JI2B19CR0R
Classification: ACTIB
NEOMYCIN SULFATEActive
Quantity: 3.3 mg in 1 mL
Code: 057Y626693
Classification: ACTIM
COLISTIN SULFATEActive
Quantity: 3 mg in 1 mL
Code: WP15DXU577
Classification: ACTIM
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
HYDROCORTISONE ACETATEActive
Quantity: 10 mg in 1 mL
Code: 3X7931PO74
Classification: ACTIB