Clinical Trials

Find trials by condition, location & phase

Drug Monographs

Browse drug monographs and information

Explore organizations and their profiles

Latest updates on trials and healthcare

Approved products by global authorities

AI-Powered Research

Discover powerful insights with advanced AI analysis tools for clinical trials.

Premium Access

Get unlimited access to our comprehensive pharmaceutical database and analytics.

FDA Approval

POLYMYXIN B SULFATE AND TRIMETHOPRIM

CompanyDirect_Rx (DUNS: 079254320)

Effective Date

June 25, 2019

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)

Registrants (1)

DUNS Number

079254320

Manufacturing Establishments (1)

Labeler

Direct_Rx

Registrant

Direct_Rx

DUNS Number

079254320

Products (1)

POLYMYXIN B SULFATE AND TRIMETHOPRIM

NDC Product Code

72189-005

Application Number

ANDA065006

Marketing Category

ANDA (C73584)

Route of Administration

OPHTHALMIC

Effective Date

June 25, 2019

Ingredients

Polymyxin BActive

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

SULFURIC ACIDInactive

Code: O40UQP6WCFClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

BENZALKONIUM CHLORIDEInactive

Code: F5UM2KM3W7Class: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Polymyxin B Sulfate/Trimethoprim SulfateActive

Code: E377MF8EQ8Class: ACTIMQuantity: 1 mg in 1 mL

© Copyright 2025. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy