Neomycin and Polymyxin B Sulfates and Hydrocortisone

Product NDC

68788-9415

11-digit product format

687889415

Labeler code

68788

Product ID

68788-9415_84bafe43-955b-44c3-8ccc-e7a8c762cb11

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

neomycin sulfate, polymyxin b sulfate and hydrocortisone

Dosage form

SUSPENSION

Route

AURICULAR (OTIC)

Labeler

Preferred Pharmaceuticals, Inc.

Application

ANDA062488

Marketing category

ANDA

Marketing start

2014-05-13

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

2019-12-31

Current FDA listing

Historical FDA.report record