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FDA Approval

Polymyxin B Sulfate and Trimethoprim

CompanyRPK Pharmaceuticals, Inc. (DUNS: 147096275)

Effective Date

June 7, 2023

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)

RPK Pharmaceuticals, Inc.

Labeler

RPK Pharmaceuticals, Inc.

DUNS Number

147096275

Products (1)

Polymyxin B Sulfate and Trimethoprim

NDC Product Code

53002-8620

Application Number

ANDA064120

Marketing Category

ANDA (C73584)

Route of Administration

OPHTHALMIC

Effective Date

February 4, 2020

Ingredients

Polymyxin BActive

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

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SULFURIC ACIDInactive

Code: O40UQP6WCFClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

BENZALKONIUM CHLORIDEInactive

Code: F5UM2KM3W7Class: IACT

Polymyxin B Sulfate/Trimethoprim SulfateActive

Code: E377MF8EQ8Class: ACTIMQuantity: 1 mg in 1 mL

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