Polymyxin B Sulfate and Trimethoprim
Approved
Approval ID
c6389773-8137-457b-ad95-d3df3bd00158
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 5, 2010
Manufacturers
FDA
STAT RX LLC USA
DUNS: 786036330
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 Code16590-233
Application NumberANDA064211
Product Classification
M
Marketing Category
C73584
G
Generic Name
Polymyxin B Sulfate and Trimethoprim
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateNovember 18, 2010
FDA Product Classification
INGREDIENTS (7)
POLYMYXIN B SULFATEActive
Quantity: 10000 1 in 1 mL
Code: 19371312D4
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRIMETHOPRIM SULFATEActive
Quantity: 1 mg in 1 mL
Code: E377MF8EQ8
Classification: ACTIB