FDA.reportPublic FDA data

SALMETEROL XINAFOATE - Food and Drug Administration

Set ID
811691fa-281f-6d95-fb49-e2337fb2e146
Type
Indexing - Product Concept
Effective date
2014-05-08
Version
1
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
These highlights do not include all the information needed to use Fluticasone Propionate/Salmeterol DISKUS safely and effectively. See full prescribing information for Fluticasone Propionate/Salmeterol DISKUS. Fluticasone Propionate/Salmeterol DISKUS inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product nameA-S Medication Solutions2026-10-06
These highlights do not include all the information needed to use Fluticasone Propionate/Salmeterol DISKUS safely and effectively. See full prescribing information for Fluticasone Propionate/Salmeterol DISKUS. Fluticasone Propionate/Salmeterol DISKUS inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product nameA-S Medication Solutions2026-10-01
These highlights do not include all the information needed to use Fluticasone Propionate/Salmeterol DISKUS safely and effectively. See full prescribing information for Fluticasone Propionate/Salmeterol DISKUS. Fluticasone Propionate/Salmeterol DISKUS inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product nameREMEDYREPACK INC.2026-09-08
These highlights do not include all the information needed to use Fluticasone Propionate/Salmeterol DISKUS safely and effectively. See full prescribing information for Fluticasone Propionate/Salmeterol DISKUS. Fluticasone Propionate/Salmeterol DISKUS inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product nameREMEDYREPACK INC.2026-09-08
These highlights do not include all the information needed to use FLUTICASONE PROPIONATE and SALMETEROL INHALATION POWDER safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE and SALMETEROL INHALATION POWDER. FLUTICASONE PROPIONATE and SALMETEROL inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product nameREMEDYREPACK INC.2026-06-11
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 (fluticasone propionate and salmeterol inhalation powder), for oral inhalation use Initial U.S. Approval: 2000Product nameA-S Medication Solutions2026-04-26
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 (fluticasone propionate and salmeterol inhalation powder), for oral inhalation use Initial U.S. Approval: 2000Product nameGlaxoSmithKline LLC2026-03-26
These highlights do not include all the information needed to use FLUTICASONE PROPIONATE and SALMETEROL INHALATION POWDER safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE and SALMETEROL INHALATION POWDER. FLUTICASONE PROPIONATE and SALMETEROL inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product nameLannett Company, Inc.2026-03-08
These highlights do not include all the information needed to use Fluticasone Propionate/Salmeterol DISKUS safely and effectively. See full prescribing information for Fluticasone Propionate/Salmeterol DISKUS. Fluticasone Propionate/Salmeterol DISKUS inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product nameREMEDYREPACK INC.2026-02-04
These highlights do not include all the information needed to use FLUTICASONE PROPIONATE and SALMETEROL INHALATION POWDER safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE and SALMETEROL INHALATION POWDER. FLUTICASONE PROPIONATE and SALMETEROL inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product nameREMEDYREPACK INC.2026-01-19
These highlights do not include all the information needed to use FLUTICASONE PROPIONATE and SALMETEROL INHALATION POWDER safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE and SALMETEROL INHALATION POWDER. FLUTICASONE PROPIONATE and SALMETEROL inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product nameREMEDYREPACK INC.2026-01-08
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 (fluticasone propionate and salmeterol inhalation powder), for oral inhalation use Initial U.S. Approval: 2000Product nameA-S Medication Solutions2025-10-29
These highlights do not include all the information needed to use FLUTICASONE PROPIONATE AND SALMETEROL INHALATION POWDER safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE AND SALMETEROL INHALATION POWDER. Fluticasone Propionate and Salmeterol inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product nameBryant Ranch Prepack2025-08-21
These highlights do not include all the information needed to use FLUTICASONE PROPIONATE AND SALMETEROL INHALATION POWDER safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE AND SALMETEROL INHALATION POWDER. Fluticasone Propionate and Salmeterol inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product nameBryant Ranch Prepack2025-08-21
These highlights do not include all the information needed to use FLUTICASONE PROPIONATE and SALMETEROL INHALATION POWDER safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE and SALMETEROL INHALATION POWDER. FLUTICASONE PROPIONATE and SALMETEROL inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product nameREMEDYREPACK INC.2025-08-12
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 (fluticasone propionate and salmeterol inhalation powder), for oral inhalation use Initial U.S. Approval: 2000Product nameA-S Medication Solutions2025-08-08
These highlights do not include all the information needed to use ADVAIR HFA safely and effectively. See full prescribing information for ADVAIR HFA. ADVAIR HFA (fluticasone propionate and salmeterol inhalation aerosol), for oral inhalation use Initial U.S. Approval: 2000Product nameA-S Medication Solutions2025-08-08
These highlights do not include all the information needed to use ADVAIR HFA safely and effectively. See full prescribing information for ADVAIR HFA. ADVAIR HFA (fluticasone propionate and salmeterol inhalation aerosol), for oral inhalation use Initial U.S. Approval: 2000Product nameA-S Medication Solutions2025-08-08
These highlights do not include all the information needed to use FLUTICASONE PROPIONATE and SALMETEROL INHALATION POWDER safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE and SALMETEROL INHALATION POWDER. FLUTICASONE PROPIONATE and SALMETEROL inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product nameREMEDYREPACK INC.2025-08-06
These highlights do not include all the information needed to use Fluticasone Propionate/Salmeterol DISKUS safely and effectively. See full prescribing information for Fluticasone Propionate/Salmeterol DISKUS. Fluticasone Propionate/Salmeterol DISKUS inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product nameREMEDYREPACK INC.2025-08-05
These highlights do not include all the information needed to use Fluticasone Propionate/Salmeterol DISKUS safely and effectively. See full prescribing information for Fluticasone Propionate/Salmeterol DISKUS. Fluticasone Propionate/Salmeterol DISKUS inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product nameREMEDYREPACK INC.2025-08-05
These highlights do not include all the information needed to use Fluticasone Propionate/Salmeterol DISKUS safely and effectively. See full prescribing information for Fluticasone Propionate/Salmeterol DISKUS. Fluticasone Propionate/Salmeterol DISKUS inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product nameREMEDYREPACK INC.2025-08-05
These highlights do not include all the information needed to use FLUTICASONE PROPIONATE and SALMETEROL INHALATION POWDER safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE and SALMETEROL INHALATION POWDER. FLUTICASONE PROPIONATE and SALMETEROL inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product namePreferred Pharmaceuticals Inc.2025-05-16
These highlights do not include all the information needed to use FLUTICASONE PROPIONATE and SALMETEROL INHALATION POWDER safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE and SALMETEROL INHALATION POWDER. FLUTICASONE PROPIONATE and SALMETEROL inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product namePreferred Pharmaceuticals Inc.2025-05-14
These highlights do not include all the information needed to use FLUTICASONE PROPIONATE AND SALMETEROL INHALATION POWDER safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE AND SALMETEROL INHALATION POWDER. Fluticasone Propionate and Salmeterol inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product nameA-S Medication Solutions2025-04-02
These highlights do not include all the information needed to use WIXELA INHUB ® safely and effectively. See full prescribing information for WIXELA INHUB ® . WIXELA INHUB ® (fluticasone propionate and salmeterol inhalation powder), for oral inhalation use Initial U.S. Approval: 2000Product nameBryant Ranch Prepack2025-02-13
These highlights do not include all the information needed to use FLUTICASONE PROPIONATE and SALMETEROL INHALATION POWDER safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE and SALMETEROL INHALATION POWDER. FLUTICASONE PROPIONATE and SALMETEROL inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product nameHikma Pharmaceuticals USA Inc. | West-Ward Columbus Inc.2024-12-05
These highlights do not include all the information needed to use FLUTICASONE PROPIONATE and SALMETEROL INHALATION POWDER safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE and SALMETEROL INHALATION POWDER. FLUTICASONE PROPIONATE and SALMETEROL inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product nameLannett Company, Inc.2024-07-11
These highlights do not include all the information needed to use Fluticasone Propionate and Salmeterol HFA safely and effectively. See full prescribing information for Fluticasone Propionate and Salmeterol HFA. Fluticasone Propionate and Salmeterol HFA inhalation aerosol, for oral inhalation use Initial U.S. Approval: 2000Product namePrasco Laboratories | GlaxoSmithKline LLC2024-05-29
These highlights do not include all the information needed to use ADVAIR HFA safely and effectively. See full prescribing information for ADVAIR HFA. ADVAIR HFA (fluticasone propionate and salmeterol inhalation aerosol), for oral inhalation use Initial U.S. Approval: 2000Product nameGlaxoSmithKline LLC2024-05-23
These highlights do not include all the information needed to use ADVAIR HFA safely and effectively. See full prescribing information for ADVAIR HFA. ADVAIR HFA (fluticasone propionate and salmeterol inhalation aerosol), for oral inhalation use Initial U.S. Approval: 2000Product nameGlaxoSmithKline LLC2024-05-23
These highlights do not include all the information needed to use FLUTICASONE PROPIONATE AND SALMETEROL INHALATION POWDER safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE AND SALMETEROL INHALATION POWDER. Fluticasone Propionate and Salmeterol inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product nameBryant Ranch Prepack2024-04-04
These highlights do not include all the information needed to use FLUTICASONE PROPIONATE AND SALMETEROL INHALATION POWDER safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE AND SALMETEROL INHALATION POWDER. Fluticasone Propionate and Salmeterol inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product nameTeva Pharmaceuticals USA, Inc.2024-02-09
These highlights do not include all the information needed to use AIRDUO ® RESPICLICK ® safely and effectively. See full prescribing information for AIRDUO RESPICLICK. AIRDUO RESPICLICK (fluticasone propionate and salmeterol) inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product nameTeva Respiratory, LLC2024-02-06
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 (fluticasone propionate and salmeterol inhalation powder), for oral inhalation use Initial U.S. Approval: 2000Product nameA-S Medication Solutions2024-01-30
These highlights do not include all the information needed to use Fluticasone Propionate/Salmeterol DISKUS safely and effectively. See full prescribing information for Fluticasone Propionate/Salmeterol DISKUS. Fluticasone Propionate/Salmeterol DISKUS inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product nameA-S Medication Solutions2024-01-22
These highlights do not include all the information needed to use Fluticasone Propionate/Salmeterol DISKUS safely and effectively. See full prescribing information for Fluticasone Propionate/Salmeterol DISKUS. Fluticasone Propionate/Salmeterol DISKUS inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product nameRPK Pharmaceuticals, Inc.2023-09-11
These highlights do not include all the information needed to use Fluticasone Propionate/Salmeterol DISKUS safely and effectively. See full prescribing information for Fluticasone Propionate/Salmeterol DISKUS. Fluticasone Propionate/Salmeterol DISKUS inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product namePrasco Laboratories | GlaxoSmithKline LLC2023-07-19
These highlights do not include all the information needed to use Fluticasone Propionate/Salmeterol DISKUS safely and effectively. See full prescribing information for Fluticasone Propionate/Salmeterol DISKUS. Fluticasone Propionate/Salmeterol DISKUS inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product namePrasco Laboratories | GlaxoSmithKline LLC2023-07-19
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 (fluticasone propionate and salmeterol inhalation powder), for oral inhalation use Initial U.S. Approval: 2000Product nameA-S Medication Solutions2023-05-16
These highlights do not include all the information needed to use Fluticasone Propionate/Salmeterol DISKUS safely and effectively. See full prescribing information for Fluticasone Propionate/Salmeterol DISKUS. Fluticasone Propionate/Salmeterol DISKUS inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product nameA-S Medication Solutions2023-02-06
These highlights do not include all the information needed to use Fluticasone Propionate/Salmeterol DISKUS safely and effectively. See full prescribing information for Fluticasone Propionate/Salmeterol DISKUS. Fluticasone Propionate/Salmeterol DISKUS inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product nameA-S Medication Solutions2023-02-06
These highlights do not include all the information needed to use SEREVENT DISKUS safely and effectively. See full prescribing information for SEREVENT DISKUS. SEREVENT DISKUS (salmeterol xinafoate inhalation powder), for oral inhalation use Initial U.S. Approval: 1994Product nameGlaxoSmithKline LLC2022-10-10
These highlights do not include all the information needed to use SEREVENT DISKUS safely and effectively. See full prescribing information for SEREVENT DISKUS. SEREVENT DISKUS (salmeterol xinafoate inhalation powder), for oral inhalation use Initial U.S. Approval: 1994Product nameGlaxoSmithKline LLC2022-10-10
These highlights do not include all the information needed to use FLUTICASONE PROPIONATE AND SALMETEROL INHALATION POWDER safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE AND SALMETEROL INHALATION POWDER. FLUTICASONE PROPIONATE and SALMETEROL inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product nameTeva Pharmaceuticals USA, Inc.2022-09-28
These highlights do not include all the information needed to use WIXELA INHUB ® safely and effectively. See full prescribing information for WIXELA INHUB ® . WIXELA INHUB ® (fluticasone propionate and salmeterol inhalation powder), for oral inhalation use Initial U.S. Approval: 2000Product nameMylan Pharmaceuticals Inc.2022-08-29
These highlights do not include all the information needed to use AIRDUO ® RESPICLICK ® safely and effectively. See full prescribing information for AIRDUO RESPICLICK. AIRDUO RESPICLICK (fluticasone propionate and salmeterol) inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product nameTeva Respiratory, LLC2021-07-31
These highlights do not include all the information needed to use FLUTICASONE PROPIONATE AND SALMETEROL INHALATION POWDER safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE AND SALMETEROL INHALATION POWDER. Fluticasone Propionate and Salmeterol inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product nameTeva Pharmaceuticals USA, Inc.2021-07-31
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 (fluticasone propionate and salmeterol inhalation powder), for oral inhalation use Initial U.S. Approval: 2000Product nameA-S Medication Solutions2021-02-16
These highlights do not include all the information needed to use Fluticasone Propionate/Salmeterol DISKUS safely and effectively. See full prescribing information for Fluticasone Propionate/Salmeterol DISKUS. Fluticasone Propionate/Salmeterol DISKUS inhalation powder, for oral inhalation use Initial U.S. Approval: 2000Product nameProficient Rx LP2020-01-01
These highlights do not include all the information needed to use SEREVENT DISKUS safely and effectively. See full prescribing information for SEREVENT DISKUS. SEREVENT DISKUS (salmeterol xinafoate inhalation powder) FOR ORAL INHALATION Initial U.S. Approval: 1994Product nameDispensing Solutions, Inc. | PSS World Medical, Inc.2012-09-27
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 INHALATION Initial U.S. Approval: 2000Product nameAidarex Pharmaceuticals LLC2012-09-10
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 INHALATION Initial U.S. Approval: 2000Product nameRebel Distributors Corp2011-07-20
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 INHALATION Initial U.S. Approval: 2000Product nameRebel Distributors Corp.2010-09-01
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 INHALATION Initial U.S. Approval: 2000Product namePhysicians Total Care, Inc.2010-06-21
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 INHALATION Initial U.S. Approval: 2000Product nameDispensing Solutions Inc.2010-03-02