POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE
POLYMYXIN B SULFATE and TRIMETHOPRIM ophthalmic solution, USP sterile
Approved
Approval ID
f144a8b9-2c30-4a8f-8951-cce576c575cd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2018
Manufacturers
FDA
Pacific Pharma, Inc.
DUNS: 877645267
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
NDC Product Code60758-908
Application NumberNDA050567
Marketing CategoryC73605
Route of AdministrationOPHTHALMIC
Effective DateJanuary 23, 2023
Generic Namepolymyxin B sulfate, trimethoprim sulfate
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