Polymyxin B Sulfate and Trimethoprim
Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP Sterile Rx Only
Approved
Approval ID
76e1be2e-eb19-48d4-9bfb-88537de839ba
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 7, 2023
Manufacturers
FDA
RPK Pharmaceuticals, Inc.
DUNS: 147096275
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 Code53002-8621
Application NumberANDA064211
Product Classification
M
Marketing Category
C73584
G
Generic Name
Polymyxin B Sulfate and Trimethoprim
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateAugust 16, 2011
FDA Product Classification
INGREDIENTS (7)
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
POLYMYXIN B SULFATEActive
Quantity: 10000 [USP'U] in 1 mL
Code: 19371312D4
Classification: ACTIM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRIMETHOPRIM SULFATEActive
Quantity: 1 mg in 1 mL
Code: E377MF8EQ8
Classification: ACTIM