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FDA Approval

Trimethoprim sulfate and Polymyxin B sulfate

CompanyProficient Rx LP (DUNS: 079196022)

Effective Date

January 1, 2021

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)

Trimethoprim sulfate and Polymyxin B sulfate

NDC Product Code

63187-193

Application Number

ANDA065006

Marketing Category

ANDA (C73584)

Route of Administration

OPHTHALMIC

Effective Date

January 1, 2021

Ingredients

sodium chlorideInactive

Code: 451W47IQ8XClass: IACT

sulfuric acidInactive

Code: O40UQP6WCFClass: IACT

Polymyxin BActive

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

benzalkonium chlorideInactive

Code: F5UM2KM3W7Class: IACT

sodium hydroxideInactive

Code: 55X04QC32IClass: IACT

waterInactive

Code: 059QF0KO0RClass: IACT

Polymyxin B Sulfate/Trimethoprim SulfateActive

Code: E377MF8EQ8Class: ACTIMQuantity: 1 mg in 1 mL

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