Neomycin and Polymyxin B Sulfates and Dexamethasone

Product NDC

13985-014

11-digit product format

139850014

Labeler code

13985

Product ID

13985-014_8d55dfcf-788d-4504-aebd-afcc98c81345

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Neomycin sulfate, Polymyxin B Sulfate, and Dexamethasone

Dosage form

OINTMENT

Route

OPHTHALMIC

Labeler

MWI/VetOne

Application

ANDA064063

Marketing category

ANDA

Marketing start

1994-07-25

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

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record