Neomycin and Polymyxin B sulfates, Bacitracin zinc

Product NDC

57237-129

11-digit product format

572370129

Labeler code

57237

Product ID

57237-129_b9658136-c2b1-492e-a9ff-8a8d4e5f5ff6

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Neomycin and Polymyxin B sulfates, Bacitracin zinc

Dosage form

OINTMENT

Route

OPHTHALMIC

Labeler

Citron Pharma LLC

Application

NDA050417

Marketing category

NDA

Marketing start

2017-04-10

Marketing end

0000-00-00

Substance

NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC

Active strength

4 mg/g; [USP'U]/g; [USP'U]/g

Pharmacologic classes

Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Decreased Cell Wall Synthesis & Repair [PE],Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]

NDC exclude flag

E

Listing certified through

2018-12-31

Current FDA listing

Historical FDA.report record