Polymyxin B Sulfate and Trimethoprim
Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP Sterile
Approved
Approval ID
12de69e0-e8de-4871-833b-30cc4a0a6965
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 21, 2018
Manufacturers
FDA
Aidarex Pharmaceuticals LLC
DUNS: 801503249
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Polymyxin B Sulfate and Trimethoprim
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53217-305
Application NumberANDA064211
Product Classification
M
Marketing Category
C73584
G
Generic Name
Polymyxin B Sulfate and Trimethoprim
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMay 23, 2018
FDA Product Classification
INGREDIENTS (7)
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYMYXIN B SULFATEActive
Quantity: 10000 [USP'U] in 1 mL
Code: 19371312D4
Classification: ACTIM
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
TRIMETHOPRIM SULFATEActive
Quantity: 1 mg in 1 mL
Code: E377MF8EQ8
Classification: ACTIM