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ADVAIR

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

Approved
Approval ID

de811b6d-ca0e-4921-a127-b10101ee0035

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 2, 2010

Manufacturers
FDA

Dispensing Solutions Inc.

DUNS: 066070785

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

fluticasone propionate and salmeterol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68258-3031
Application NumberNDA021077
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluticasone propionate and salmeterol
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION), ORAL
Effective DateMarch 2, 2010
FDA Product Classification

INGREDIENTS (3)

SALMETEROL XINAFOATEActive
Quantity: 50 ug in 1 1
Code: 6EW8Q962A5
Classification: ACTIB
FLUTICASONE PROPIONATEActive
Quantity: 250 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT

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ADVAIR - FDA Drug Approval Details