Neomycin Polymyxin B Sulfates and Dexamethasone

Product NDC

13985-028

11-digit product format

139850028

Labeler code

13985

Product ID

13985-028_01e58ae0-cdcf-4c1f-bfb9-9d0fc3ebd002

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone

Dosage form

SUSPENSION/ DROPS

Route

OPHTHALMIC

Labeler

MWI/VetOne

Application

ANDA064135

Marketing category

ANDA

Marketing start

1995-09-13

Marketing end

0000-00-00

Substance

NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE

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

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record