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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

9e0bdea8-df9b-4873-b24b-919cebff5edd

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 1, 2010

Manufacturers
FDA

Rebel Distributors Corp.

DUNS: 118802834

Products 2

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 Code21695-197
Application NumberNDA021077
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluticasone propionate and salmeterol
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION), ORAL
Effective DateSeptember 2, 2009
FDA Product Classification

INGREDIENTS (3)

FLUTICASONE PROPIONATEActive
Quantity: 500 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB
SALMETEROL XINAFOATEActive
Quantity: 50 ug in 1 1
Code: 6EW8Q962A5
Classification: ACTIB
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT

fluticasone propionate and salmeterol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-196
Application NumberNDA021077
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluticasone propionate and salmeterol
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION), ORAL
Effective DateSeptember 2, 2009
FDA Product Classification

INGREDIENTS (3)

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

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ADVAIR - FDA Drug Approval Details