ADVAIR DISKUS

Basic Information

Product Name

ADVAIR DISKUS

FDA Product Code

54868-4516

Regulatory Information

NDC Product Code

54868-4516

Application Number

NDA021077

Marketing Category

C73594

Effective Date

November 12, 2010

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use ADVAIR DISKUS safely and effectively. See full prescribing information for ADVAIR DISKUS.ADVAIR DISKUS 100/50(fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder)ADVAIR DISKUS 250/50(fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder)ADVAIR DISKUS 500/50(fluticasone propionate 500 mcg and salmeterol 50 mcg inhalation powder)FOR ORAL INHALATIONInitial U.S. Approval: 2000

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

SALMETEROL XINAFOATE

Quantity: 50 ug in 1 1

Code: 6EW8Q962A5

Class Code: ACTIB

FLUTICASONE PROPIONATE

Quantity: 500 ug in 1 1

Code: O2GMZ0LF5W

Class Code: ACTIB

Inactive Ingredients

LACTOSE

Code: J2B2A4N98G

Class Code: IACT

Active Moieties

FLUTICASONE

Code: CUT2W21N7U

SALMETEROL

Code: 2I4BC502BT