Neomycin and Polymyxin B Sulfates and Dexamethasone

Product NDC

68788-6841

11-digit product format

687886841

Labeler code

68788

Product ID

68788-6841_288cad06-8bc1-4c2f-abf6-0f74d6e1b96e

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Neomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone

Dosage form

OINTMENT

Route

OPHTHALMIC

Labeler

Preferred Pharmaceuticals Inc.

Application

ANDA064063

Marketing category

ANDA

Marketing start

2016-11-29

Marketing end

0000-00-00

Substance

NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE

Active strength

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

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