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FDA Approval

ADVAIR DISKUS

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
June 21, 2010
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Salmeterol(50 ug in 1 1)
Fluticasone propionate(500 ug in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Physicians Total Care, Inc.

Physicians Total Care, Inc.

194123980

Products3

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

ADVAIR DISKUS

Product Details

NDC Product Code
54868-4516
Application Number
NDA021077
Marketing Category
NDA (C73594)
Route of Administration
RESPIRATORY (INHALATION), ORAL
Effective Date
November 12, 2010
Code: 6EW8Q962A5Class: ACTIBQuantity: 50 ug in 1 1
Code: O2GMZ0LF5WClass: ACTIBQuantity: 500 ug in 1 1
LACTOSEInactive
Code: J2B2A4N98GClass: IACT

ADVAIR DISKUS

Product Details

NDC Product Code
54868-4517
Application Number
NDA021077
Marketing Category
NDA (C73594)
Route of Administration
RESPIRATORY (INHALATION), ORAL
Effective Date
November 12, 2010
Code: O2GMZ0LF5WClass: ACTIBQuantity: 250 ug in 1 1
Code: 6EW8Q962A5Class: ACTIBQuantity: 50 ug in 1 1
LACTOSEInactive
Code: J2B2A4N98GClass: IACT

ADVAIR DISKUS

Product Details

NDC Product Code
54868-4518
Application Number
NDA021077
Marketing Category
NDA (C73594)
Route of Administration
RESPIRATORY (INHALATION), ORAL
Effective Date
November 12, 2010
Code: O2GMZ0LF5WClass: ACTIBQuantity: 100 ug in 1 1
Code: 6EW8Q962A5Class: ACTIBQuantity: 50 ug in 1 1
LACTOSEInactive
Code: J2B2A4N98GClass: IACT
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