Coly-Mycin S

Product NDC

63481-421

11-digit product format

634810421

Labeler code

63481

Product ID

63481-421_78be60c0-e9a1-409c-8707-016e83e7cb06

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate

Dosage form

SUSPENSION

Route

AURICULAR (OTIC)

Labeler

Endo Pharmaceuticals Inc.

Application

NDA050356

Marketing category

NDA

Marketing start

2016-04-18

Marketing end

2020-04-30

Substance

COLISTIN SULFATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE; HYDROCORTISONE ACETATE

Active strength

3 mg/mL; mg/mL; mg/mL; mg/mL

Pharmacologic classes

Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record