POLYMYXIN B SULFATE AND TRIMETHOPRIM
POLYMYXIN B SULFATE AND TRIMETHOPRIM
Approved
Approval ID
8c27962d-62b5-30e6-e053-2a95a90a49c6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 25, 2019
Manufacturers
FDA
Direct_Rx
DUNS: 079254320
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 Code72189-005
Application NumberANDA065006
Product Classification
M
Marketing Category
C73584
G
Generic Name
POLYMYXIN B SULFATE AND TRIMETHOPRIM
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJune 25, 2019
FDA Product Classification
INGREDIENTS (7)
POLYMYXIN B SULFATEActive
Quantity: 10000 [USP'U] in 1 mL
Code: 19371312D4
Classification: ACTIM
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRIMETHOPRIM SULFATEActive
Quantity: 1 mg in 1 mL
Code: E377MF8EQ8
Classification: ACTIM