Trimethoprim sulfate and Polymyxin B sulfate
Trimethoprim Sulfate and Polymyxin B Sulfate Ophthalmic Solution
Approved
Approval ID
2c5579eb-ad81-415e-8dcb-9f1c94c897ae
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2021
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Trimethoprim sulfate and Polymyxin B sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63187-193
Application NumberANDA065006
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trimethoprim sulfate and Polymyxin B sulfate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 1, 2021
FDA Product Classification
INGREDIENTS (7)
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
sulfuric acidInactive
Code: O40UQP6WCF
Classification: IACT
Polymyxin B sulfateActive
Quantity: 10000 [USP'U] in 1 mL
Code: 19371312D4
Classification: ACTIM
benzalkonium chlorideInactive
Code: F5UM2KM3W7
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