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U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Search results from the "OB_Rx" table for query on "021077."



Active Ingredient: FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Dosage Form;Route: POWDER;INHALATION
Proprietary Name: ADVAIR DISKUS 100/50
Applicant: GLAXO GRP LTD
Strength: 0.1MG/INH;EQ 0.05MG BASE/INH
Application Number: N021077
Product Number: 001
Approval Date: Aug 24, 2000
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Dosage Form;Route: POWDER;INHALATION
Proprietary Name: ADVAIR DISKUS 250/50
Applicant: GLAXO GRP LTD
Strength: 0.25MG/INH;EQ 0.05MG BASE/INH
Application Number: N021077
Product Number: 002
Approval Date: Aug 24, 2000
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Dosage Form;Route: POWDER;INHALATION
Proprietary Name: ADVAIR DISKUS 500/50
Applicant: GLAXO GRP LTD
Strength: 0.5MG/INH;EQ 0.05MG BASE/INH
Application Number: N021077
Product Number: 003
Approval Date: Aug 24, 2000
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

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FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Update Frequency:

Orange Book Data - Monthly
Generic Drug Product Information & Patent Information - Daily
Orange Book Data Updated Through June 2014
Patent and Generic Drug Product Data Last Updated July 28, 2014

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