Neomycin and Polymyxin B Sulfates and Hydrocortisone

Product NDC

49999-439

11-digit product format

499990439

Labeler code

49999

Product ID

49999-439_3da797e8-dd64-4d3b-a1fa-f4734bbba457

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Neomycin and Polymyxin B Sulfates and Hydrocortisone

Dosage form

SUSPENSION/ DROPS

Route

AURICULAR (OTIC)

Labeler

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

Application

ANDA064065

Marketing category

ANDA

Marketing start

2012-01-24

Marketing end

0000-00-00

Substance

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Active strength

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

Pharmacologic classes

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

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record