ARCAPTA NEOHALER

Product NDC

63402-675

11-digit product format

634020675

Labeler code

63402

Product ID

63402-675_1250b6c5-cdae-4771-ae60-1463c97cecca

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

INDACATEROL MALEATE

Dosage form

CAPSULE

Route

ORAL; RESPIRATORY (INHALATION)

Labeler

Sunovion Pharmaceuticals Inc.

Application

NDA022383

Marketing category

NDA

Marketing start

2011-07-01

Marketing end

2021-01-31

Substance

INDACATEROL MALEATE

Active strength

75 ug/1

Pharmacologic classes

Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record