POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE
POLYMYXIN B SULFATE and TRIMETHOPRIM
Approved
Approval ID
0461401a-17c1-460f-b9ec-ff1cfe514f57
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2012
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
polymyxin B sulfate, trimethoprim sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-609
Application NumberNDA050567
Product Classification
M
Marketing Category
C73605
G
Generic Name
polymyxin B sulfate, trimethoprim sulfate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 3, 2012
FDA Product Classification
INGREDIENTS (7)
polymyxin B sulfateActive
Quantity: 10000 [USP'U] in 1 mL
Code: 19371312D4
Classification: ACTIB
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: ACTIB