MedPath
FDA Approval

Polymyxin B Sulfate and Trimethoprim

August 27, 2023

HUMAN PRESCRIPTION DRUG LABEL

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

Manufacturing Establishments (1)

A-S Medication Solutions

A-S Medication Solutions

830016429

Products (1)

Polymyxin B Sulfate and Trimethoprim

50090-2925

ANDA064211

ANDA (C73584)

OPHTHALMIC

August 16, 2011

SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
Code: 19371312D4Class: ACTIMQuantity: 10000 [USP'U] in 1 mL
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7Class: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCFClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
Code: E377MF8EQ8Class: ACTIMQuantity: 1 mg in 1 mL

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Polymyxin B Sulfate and Trimethoprim

Label Image


DOSAGE & ADMINISTRATION SECTION

DOSAGE AND ADMINISTRATION

In mild to moderate infections, instill one drop in the affected eye(s) every three hours (maximum of 6 doses per day) for a period of 7 to 10 days.


HOW SUPPLIED SECTION

HOW SUPPLIED

Product: 50090-2925

NDC: 50090-2925-0 10 mL in a BOTTLE, PLASTIC


SPL UNCLASSIFIED SECTION

Manufactured by

Alcon Laboratories, Inc.

Fort Worth, Texas 76134 for

Sandoz Inc.

Princeton, NJ 08540

Revised: August 2021

300049866-0821


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