Dulera

Product NDC

50090-1916

11-digit product format

500901916

Labeler code

50090

Product ID

50090-1916_47947df3-74d8-4025-a353-59321104147a

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

mometasone furoate and formoterol fumarate dihydrate

Dosage form

AEROSOL

Route

RESPIRATORY (INHALATION)

Labeler

A-S Medication Solutions

Application

NDA022518

Marketing category

NDA

Marketing start

2010-06-22

Marketing end

0000-00-00

Substance

MOMETASONE FUROATE; FORMOTEROL FUMARATE

Active strength

200 ug/1; ug/1

Pharmacologic classes

Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record