Neomycin and Polymyxin B Sulfates and Hydrocortisone

Product NDC

66267-954

11-digit product format

662670954

Labeler code

66267

Product ID

66267-954_9cbe7666-e0a5-54fb-e053-2995a90a63fb

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone

Dosage form

SOLUTION/ DROPS

Route

AURICULAR (OTIC)

Labeler

NuCare Pharmaceuticals, Inc.

Application

ANDA064053

Marketing category

ANDA

Marketing start

1995-12-29

Marketing end

0000-00-00

Substance

NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE

Active strength

4 mg/mL; [USP'U]/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

2021-12-31

Current FDA listing

Historical FDA.report record