FDA.reportPublic FDA data

LEVALBUTEROL TARTRATE - Food and Drug Administration

Set ID
a511b237-73ca-80ef-2a42-a935d09028ad
Type
Indexing - Product Concept
Effective date
2014-05-08
Version
1
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
Levalbuterol Inhalation Solution, USP These highlights do not include all the information needed to use LEVALBUTEROL INHALATION SOLUTION, USP safely and effectively. See full prescribing information for LEVALBUTEROL INHALATION SOLUTION, USP. LEVALBUTEROL INHALATION SOLUTION, USP, for inhalation use Initial U.S. Approval: 1999 Rx onlyProduct nameRitedose Pharmaceuticals, LLC | The Ritedose Corporation2025-12-10
These highlights do not include all the information needed to use XOPENEX HFA ® safely and effectively. See full prescribing information for XOPENEX HFA ® . XOPENEX HFA ® (levalbuterol tartrate) inhalation aerosol, for oral inhalation use Initial U.S. Approval: 1999Product nameLupin Pharmaceuticals, Inc.2025-06-02
These highlights do not include all the information needed to use LEVALBUTEROL INHALATION SOLUTION safely and effectively. See full prescribing information for LEVALBUTEROL INHALATION SOLUTION. LEVALBUTEROL inhalation solution, for inhalation use Initial U.S. Approval: 1999Product nameLuoxin Aurovitas Pharma (Chengdu) Co., Ltd.2024-12-24
These highlights do not include all the information needed to use LEVALBUTEROL INHALATION SOLUTION safely and effectively. See full prescribing information for LEVALBUTEROL INHALATION SOLUTION. LEVALBUTEROL inhalation solution, for inhalation use Initial U.S. Approval: 1999Product nameAurobindo Pharma Limited | Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.2024-12-24
These highlights do not include all the information needed to use LEVALBUTEROL INHALATION SOLUTION (CONCENTRATE) safely and effectively. See full prescribing information for LEVALBUTEROL INHALATION SOLUTION (CONCENTRATE). LEVALBUTEROL inhalation solution (concentrate), for inhalation use Initial U.S. Approval: 1999Product nameAurobindo Pharma Limited | Aarti Pharmalabs Limited | Eugia Pharma Specialities Limited2023-10-31
These highlights do not include all the information needed to use LEVALBUTEROL INHALATION SOLUTION, USP safely and effectively. See full prescribing information for LEVALBUTEROL INHALATION SOLUTION, USP. LEVALBUTEROL INHALATION SOLUTION, USP, for inhalation use Initial U.S. Approval: 1999 Rx onlyProduct nameBryant Ranch Prepack2023-09-14
These highlights do not include all the information needed to use LEVALBUTEROL INHALATION SOLUTION, USP safely and effectively. See full prescribing information for LEVALBUTEROL INHALATION SOLUTION, USP. LEVALBUTEROL INHALATION SOLUTION, USP, for inhalation use Initial U.S. Approval: 1999 Rx onlyProduct nameBryant Ranch Prepack2023-09-14
These highlights do not include all the information needed to use LEVALBUTEROL INHALATION SOLUTION, USP safely and effectively. See full prescribing information for LEVALBUTEROL INHALATION SOLUTION, USP. LEVALBUTEROL INHALATION SOLUTION, USP, for inhalation use Initial U.S. Approval: 1999 Rx onlyProduct nameBryant Ranch Prepack2023-09-13
These highlights do not include all the information needed to use Levalbuterol tartrate HFA inhalation aerosol safely and effectively. See full prescribing information for Levalbuterol tartrate HFA inhalation aerosol. Levalbuterol tartrate HFA inhalation aerosol, for oral inhalation use Initial U.S. Approval: 1999Product nameActavis Pharma, Inc.2023-07-01
These highlights do not include all the information needed to use LEVALBUTEROL INHALATION SOLUTION, USP safely and effectively. See full prescribing information for LEVALBUTEROL INHALATION SOLUTION, USP. LEVALBUTEROL inhalation solution, for oral inhalation use Initial U.S. Approval: 1999 Rx onlyProduct nameA-S Medication Solutions2023-02-28
Levalbuterol tartrate HFA inhalation aerosol, for oral inhalation useProduct namePraxis, LLC2023-01-01
These highlights do not include all the information needed to use Levalbuterol tartrate HFA inhalation aerosol safely and effectively. See full prescribing information for Levalbuterol tartrate HFA inhalation aerosol. Levalbuterol tartrate HFA inhalation aerosol, for oral inhalation use Initial U.S. Approval: 1999Product nameProficient Rx LP2022-12-01
These highlights do not include all the information needed to use XOPENEX ® Inhalation Solution Concentrate safely and effectively. See full prescribing information for XOPENEX ® Inhalation Solution Concentrate. XOPENEX ® (levalbuterol hydrochloride) Inhalation Solution Concentrate Initial U.S. Approval: 1999Product nameAkorn2022-09-14
These highlights do not include all the information needed to use XOPENEX ® Inhalation Solution safely and effectively. See full prescribing information for XOPENEX ® Inhalation Solution. XOPENEX ® (levalbuterol hydrochloride) Inhalation Solution Initial U.S. Approval: 1999Product nameAkorn2022-09-14
These highlights do not include all the information needed to use LEVALBUTEROL INHALATION SOLUTION, USP safely and effectively. See full prescribing information for LEVALBUTEROL INHALATION SOLUTION, USP. LEVALBUTEROL inhalation solution, for oral inhalation use Initial U.S. Approval: 1999 Rx onlyProduct nameBurel Pharmaceuticals, LLC2021-07-01
These highlights do not include all the information needed to use LEVALBUTEROL INHALATION SOLUTION safely and effectively. See full prescribing information for LEVALBUTEROL INHALATION SOLUTION. LEVALBUTEROL inhalation solution Initial U.S. Approval: 1999Product nameNuCare Pharmaceuticals,Inc.2021-02-02
These highlights do not include all the information needed to use LEVALBUTEROL INHALATION SOLUTION safely and effectively. See full prescribing information for LEVALBUTEROL INHALATION SOLUTION. LEVALBUTEROL inhalation solution Initial U.S. Approval: 1999Product nameSun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Medicare Limited2020-04-23
These highlights do not include all the information needed to use LEVALBUTEROL INHALATION SOLUTION, USP safely and effectively. See full prescribing information for LEVALBUTEROL INHALATION SOLUTION, USP. LEVALBUTEROL inhalation solution, USP, for oral inhalation use Initial U.S. Approval: 1999 Rx onlyProduct nameMylan Pharmaceuticals Inc.2020-02-17
These highlights do not include all the information needed to use LEVALBUTEROL INHALATION SOLUTION (CONCENTRATE) safely and effectively. See full prescribing information for LEVALBUTEROL INHALATION SOLUTION (CONCENTRATE). LEVALBUTEROL inhalation solution (concentrate) Initial U.S. Approval: 1999Product nameMylan Pharmaceuticals Inc.2019-11-11
These highlights do not include all the information needed to use LEVALBUTEROL INHALATION SOLUTION safely and effectively. See full prescribing information for LEVALBUTEROL INHALATION SOLUTION. LEVALBUTEROL inhalation solution, for inhalation use Initial U.S. Approval: 1999Product nameProficient Rx LP2019-11-01
These highlights do not include all the information needed to use LEVALBUTEROL INHALATION SOLUTION, USP safely and effectively. See full prescribing information for LEVALBUTEROL INHALATION SOLUTION, USP. LEVALBUTEROL INHALATION SOLUTION, USP, for inhalation use Initial U.S. Approval: 1999 Rx onlyProduct nameAmneal Pharmaceuticals of New York LLC | The Ritedose Corporation2019-06-29
These highlights do not include all the information needed to use LEVALBUTEROL INHALATION SOLUTION safely and effectively. See full prescribing information for LEVALBUTEROL INHALATION SOLUTION. LEVALBUTEROL inhalation solution Initial U.S. Approval: 1999Product nameTeva Pharmaceuticals USA, Inc.2019-01-31
Ritedose Pharmaceuticals, LLC human prescription drug labelProduct nameRitedose Pharmaceuticals, LLC2012-12-14
XOPENEX HFA ® (levalbuterol tartrate) Inhalation AerosolProduct namePhysicians Total Care, Inc.2012-05-07
Xopenex ® (levalbuterol HCl) Inhalation Solution 0.31 mg*, 0.63 mg*, 1.25 mg*Product nameRebel Distributors Corp2010-12-01
Physicians Total Care, Inc. human prescription drug labelProduct namePhysicians Total Care, Inc.2009-12-01