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FDA Approval

Polymyxin B Sulfate and Trimethoprim

CompanyProficient Rx LP (DUNS: 079196022)

Effective Date

April 1, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Polymyxin B(10000 [USP'U] in 1 mL)

Polymyxin B Sulfate/Trimethoprim Sulfate(1 mg in 1 mL)

Manufacturing Establishments (1)

Proficient Rx LP

Labeler

Proficient Rx LP

DUNS Number

079196022

Products (1)

Polymyxin B Sulfate and Trimethoprim

NDC Product Code

63187-631

Application Number

ANDA064120

Marketing Category

ANDA (C73584)

Route of Administration

OPHTHALMIC

Effective Date

April 1, 2022

Ingredients

BENZALKONIUM CHLORIDEInactive

Code: F5UM2KM3W7Class: IACT

Polymyxin BActive

Code: 19371312D4Class: ACTIMQuantity: 10000 [USP'U] in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

SULFURIC ACIDInactive

Code: O40UQP6WCFClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

Polymyxin B Sulfate/Trimethoprim SulfateActive

Code: E377MF8EQ8Class: ACTIMQuantity: 1 mg in 1 mL

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