Neomycin and Polymyxin B Sulfates and Hydrocortisone

Product NDC

55700-282

11-digit product format

557000282

Labeler code

55700

Product ID

55700-282_fe7d46ad-736d-406f-8441-187d569a488b

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

neomycin sulfate, polymyxin b sulfate and hydrocortisone

Dosage form

SOLUTION

Route

AURICULAR (OTIC)

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

ANDA062423

Marketing category

ANDA

Marketing start

2003-03-18

Marketing end

0000-00-00

Substance

NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE

Active strength

4 mg/mL; [iU]/mL; mg/mL

Pharmacologic classes

Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record