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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 064120


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NDA 064120 describes TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, which is a drug marketed by Bausch And Lomb, Epic Pharma Llc, Sandoz, and Somerset Theraps Llc, and is included in four NDAs. It is available from nine suppliers. Additional details are available on the TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE profile page.

The generic ingredient in TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE is polymyxin b sulfate; trimethoprim sulfate. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the polymyxin b sulfate; trimethoprim sulfate profile page.
Summary for 064120
Tradename:TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE
Applicant:Bausch And Lomb
Ingredient:polymyxin b sulfate; trimethoprim sulfate
Patents:0
Pharmacology for NDA: 064120
Mechanism of ActionCytochrome P450 2C8 Inhibitors
Dihydrofolate Reductase Inhibitors
Organic Cation Transporter 2 Inhibitors
Suppliers and Packaging for NDA: 064120
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE polymyxin b sulfate; trimethoprim sulfate SOLUTION/DROPS;OPHTHALMIC 064120 ANDA Bausch & Lomb Incorporated 24208-315 24208-315-10 1 BOTTLE, DROPPER in 1 CARTON (24208-315-10) / 10 mL in 1 BOTTLE, DROPPER
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE polymyxin b sulfate; trimethoprim sulfate SOLUTION/DROPS;OPHTHALMIC 064120 ANDA Proficient Rx LP 63187-631 63187-631-10 1 BOTTLE, DROPPER in 1 CARTON (63187-631-10) / 10 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength10,000 UNITS/ML;EQ 1MG BASE/ML
Approval Date:Feb 14, 1997TE:ATRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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