POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE

Product NDC

50090-2064

11-digit product format

500902064

Labeler code

50090

Product ID

50090-2064_42789948-beb9-4385-8976-e0fd766f5599

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

polymyxin B sulfate, trimethoprim sulfate

Dosage form

SOLUTION/ DROPS

Route

OPHTHALMIC

Labeler

A-S Medication Solutions

Application

NDA050567

Marketing category

NDA AUTHORIZED GENERIC

Marketing start

1997-04-29

Marketing end

0000-00-00

Substance

POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE

Active strength

10000 [USP'U]/mL; mg/mL

Pharmacologic classes

Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record