Polymyxin B Sulfate and Trimethoprim
(Sterile)
Approved
Approval ID
000775ae-38dc-40ea-b96f-a0baf5d03511
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 12, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-2398
Application NumberANDA064120
Product Classification
M
Marketing Category
C73584
G
Generic Name
Polymyxin B Sulfate and Trimethoprim Sulfate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJune 1, 2023
FDA Product Classification
INGREDIENTS (7)
POLYMYXIN B SULFATEActive
Quantity: 10000 [USP'U] in 1 mL
Code: 19371312D4
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
TRIMETHOPRIM SULFATEActive
Quantity: 1 mg in 1 mL
Code: E377MF8EQ8
Classification: ACTIM