FDA.reportPublic FDA data

FORMOTEROL FUMARATE - Food and Drug Administration

Set ID
0c06c4f4-ea2d-4e6a-a22a-0cf292716367
Type
Indexing - product concept
Effective date
2025-03-03
Version
4
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
These highlights do not include all the information needed to use DULERA safely and effectively. See full prescribing information for DULERA. DULERA ® (mometasone furoate and formoterol fumarate dihydrate) inhalation aerosol, for oral inhalation use Initial U.S. Approval: 2010Product nameOrganon LLC2026-07-10
These highlights do not include all the information needed to use FORMOTEROL FUMARATE INHALATION SOLUTION safely and effectively. See full prescribing information for FORMOTEROL FUMARATE INHALATION SOLUTION. FORMOTEROL FUMARATE inhalation solution Initial U.S. Approval: 2001Product nameLifestar Pharma LLC | Mankind Pharma Limited2026-05-01
These highlights do not include all the information needed to use FORMOTEROL FUMARATE INHALATION SOLUTION safely and effectively. See full prescribing information for FORMOTEROL FUMARATE INHALATION SOLUTION. FORMOTEROL FUMARATE inhalation solution Initial U.S. Approval: 2001Product nameNorthStar RxLLC | Mankind Pharma Limited2026-05-01
These highlights do not include all the information needed to use BREZTRI AEROSPHERE safely and effectively. See full prescribing information for BREZTRI AEROSPHERE. BREZTRI AEROSPHERE ® (budesonide, glycopyrrolate, and formoterol fumarate) inhalation aerosol, for oral inhalation use Initial U.S. Approval: 2020Product nameAstraZeneca Pharmaceuticals LP2026-04-27
These highlights do not include all the information needed to use BREZTRI AEROSPHERE safely and effectively. See full prescribing information for BREZTRI AEROSPHERE. BREZTRI AEROSPHERE ® (budesonide, glycopyrrolate, and formoterol fumarate) inhalation aerosol, for oral inhalation use Initial U.S. Approval: 2020Product nameAstraZeneca Pharmaceuticals LP2026-04-27
These highlights do not include all the information needed to use BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL safely and effectively. See full prescribing information for BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 2006Product nameSportpharm LLC2026-04-24
These highlights do not include all the information needed to use FORMOTEROL FUMARATE INHALATION SOLUTION safely and effectively. See full prescribing information for FORMOTEROL FUMARATE INHALATION SOLUTION. FORMOTEROL FUMARATE inhalation solution Initial U.S. Approval: 2001Product nameMajor Pharmaceuticals | Mankind Pharma Limited2026-03-25
These highlights do not include all the information needed to use SYMBICORT safely and effectively. See full prescribing information for SYMBICORT. SYMBICORT ® (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 2006Product nameSportpharm LLC2026-03-12
These highlights do not include all the information needed to use DULERA safely and effectively. See full prescribing information for DULERA. DULERA ® (mometasone furoate and formoterol fumarate dihydrate) inhalation aerosol, for oral inhalation use Initial U.S. Approval: 2010Product nameOrganon LLC2026-01-30
These highlights do not include all the information needed to use FORMOTEROL FUMARATE INHALATION SOLUTION safely and effectively. See full prescribing information for FORMOTEROL FUMARATE INHALATION SOLUTION. FORMOTEROL FUMARATE inhalation solution Initial U.S. Approval: 2001Product nameAlembic Pharmaceuticals Inc. | Rommelag CDMO GmbH2025-12-23
Formoterol Fumarate Inhalation Solution These highlights do not include all the information needed to use Formoterol Fumarate Inhalation Solution safely and effectively. See full prescribing information for Formoterol Fumarate Inhalation Solution. Initial U.S. Approval: 2001Product nameRitedose Pharmaceuticals, LLC | The Ritedose Corporation2025-12-10
These highlights do not include all the information needed to use BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL safely and effectively. See full prescribing information for BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 2006Product nameSportpharm, Inc. dba Sportpharm2025-11-19
These highlights do not include all the information needed to use BREYNA safely and effectively. See full prescribing information for BREYNA . BREYNA ® (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 2006Product nameMylan Pharmaceuticals Inc.2025-11-15
These highlights do not include all the information needed to use FORMOTEROL FUMARATE INHALATION SOLUTION safely and effectively. See full prescribing information for FORMOTEROL FUMARATE INHALATION SOLUTION. FORMOTEROL FUMARATE inhalation solution Initial U.S. Approval: 2001Product nameIngenus Pharmaceuticals, LLC2025-06-05
These highlights do not include all the information needed to use FORMOTEROL FUMARATE INHALATION SOLUTION safely and effectively. See full prescribing information for FORMOTEROL FUMARATE INHALATION SOLUTION. FORMOTEROL FUMARATE inhalation solution Initial U.S. Approval: 2001Product nameDevatis, Inc. | Deva Holding AS2025-04-10
These highlights do not include all the information needed to use BREYNA safely and effectively. See full prescribing information for BREYNA . BREYNA ® (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 2006Product nameMylan Pharmaceuticals Inc.2025-02-27
These highlights do not include all the information needed to use FORMOTEROL FUMARATE INHALATION SOLUTION safely and effectively. See full prescribing information for FORMOTEROL FUMARATE INHALATION SOLUTION. FORMOTEROL FUMARATE inhalation solution Initial U.S. Approval: 2001Product nameDr. Reddy's Laboratories Inc. | Dr. Reddys Laboratories Limited-FTO-92025-01-30
These highlights do not include all the information needed to use FORMOTEROL FUMARATE INHALATION SOLUTION safely and effectively. See full prescribing information for FORMOTEROL FUMARATE INHALATION SOLUTION. FORMOTEROL FUMARATE Inhalation Solution Initial U.S. Approval: 2001Product nameLupin Pharmaceuticals, Inc.2025-01-13
These highlights do not include all the information needed to use BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL safely and effectively. See full prescribing information for BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 2006Product nameA-S Medication Solutions2024-10-22
These highlights do not include all the information needed to use SYMBICORT safely and effectively. See full prescribing information for SYMBICORT. SYMBICORT ® (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 2006Product nameA-S Medication Solutions2024-10-22
These highlights do not include all the information needed to use FORMOTEROL FUMARATE INHALATION SOLUTION safely and effectively. See full prescribing information for FORMOTEROL FUMARATE INHALATION SOLUTION. FORMOTEROL FUMARATE inhalation solution, for oral inhalation use Initial U.S. Approval: 2001Product nameMicro Labs Limited2024-09-26
These highlights do not include all the information needed to use SYMBICORT safely and effectively. See full prescribing information for SYMBICORT. SYMBICORT ® (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 2006Product nameA-S Medication Solutions2024-06-28
These highlights do not include all the information needed to use SYMBICORT safely and effectively. See full prescribing information for SYMBICORT. SYMBICORT ® (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 2006Product nameA-S Medication Solutions2024-04-15
These highlights do not include all the information needed to use SYMBICORT safely and effectively. See full prescribing information for SYMBICORT. SYMBICORT ® (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 2006Product nameA-S Medication Solutions2024-04-15
These highlights do not include all the information needed to use FORMOTEROL FUMARATE INHALATION SOLUTION safely and effectively. See full prescribing information for FORMOTEROL FUMARATE INHALATION SOLUTION. FORMOTEROL FUMARATE inhalation solution, for respiratory use Initial U.S. Approval: 2001Product nameBryant Ranch Prepack2024-01-11
These highlights do not include all the information needed to use FORMOTEROL FUMARATE INHALATION SOLUTION safely and effectively. See full prescribing information for FORMOTEROL FUMARATE INHALATION SOLUTION. FORMOTEROL FUMARATE inhalation solution, for respiratory use Initial U.S. Approval: 2001Product nameBryant Ranch Prepack2024-01-11
These highlights do not include all the information needed to use BEVESPI AEROSPHERE safely and effectively. See full prescribing information for BEVESPI AEROSPHERE. BEVESPI AEROSPHERE ® (glycopyrrolate and formoterol fumarate) inhalation aerosol, for oral inhalation use Initial U.S. Approval: 2016Product nameAstraZeneca Pharmaceuticals LP2023-03-24
These highlights do not include all the information needed to use BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL safely and effectively. See full prescribing information for BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 2006Product nameA-S Medication Solutions2023-02-06
These highlights do not include all the information needed to use BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL safely and effectively. See full prescribing information for BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL. BUDESONIDE and FORMOTEROL FUMARATE DIHYDRATE inhalation aerosol, for oral inhalation use Initial U.S. Approval: 2006Product nameTeva Pharmaceuticals, Inc.2022-11-01
These highlights do not include all the information needed to use DUAKLIR PRESSAIR safely and effectively. See full prescribing information for DUAKLIR PRESSAIR. DUAKLIR ® PRESSAIR ® (aclidinium bromide and formoterol fumarate) inhalation powder, for oral inhalation Initial U.S. Approval: 2019Product nameCovis Pharma US, Inc2022-08-01
These highlights do not include all the information needed to use BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL safely and effectively. See full prescribing information for BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 2006Product nameRPK Pharmaceuticals, Inc.2022-03-30
These highlights do not include all the information needed to use BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL safely and effectively. See full prescribing information for BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 2006Product nameRPK Pharmaceuticals, Inc.2020-12-21
These highlights do not include all the information needed to use FORMOTEROL FUMARATE INHALATION SOLUTION safely and effectively. See full prescribing information for FORMOTEROL FUMARATE INHALATION SOLUTION . FORMOTEROL FUMARATE inhalation solution, for oral inhalation use Initial U.S. Approval: 2001Product nameMylan Pharmaceuticals Inc.2020-12-15
These highlights do not include all the information needed to use FORMOTEROL FUMARATE INHALATION SOLUTION safely and effectively. See full prescribing information for FORMOTEROL FUMARATE INHALATION SOLUTION. FORMOTEROL FUMARATE inhalation solution, for respiratory use Initial U.S. Approval: 2001Product nameTeva Pharmaceuticals USA, Inc.2020-10-31
These highlights do not include all the information needed to use BREYNA safely and effectively. See full prescribing information for BREYNA . BREYNA™ (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 2006Product nameMylan Pharmaceuticals Inc.2020-09-15
These highlights do not include all the information needed to use BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL safely and effectively. See full prescribing information for BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 2006Product nameAstraZeneca Pharmaceuticals LP2019-07-24
These highlights do not include all the information needed to use SYMBICORT safely and effectively. See full prescribing information for SYMBICORT. SYMBICORT ® (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 2006Product nameAstraZeneca Pharmaceuticals LP | AstraZeneca PLC2019-07-24
These highlights do not include all the information needed to use PERFOROMIST INHALATION SOLUTION safely and effectively. See full prescribing information for PERFOROMIST INHALATION SOLUTION. PERFOROMIST ® (formoterol fumarate) Inhalation Solution Initial U.S. Approval: 2001Product nameViatris Specialty LLC2019-05-31
These highlights do not include all the information needed to use PERFOROMIST INHALATION SOLUTION safely and effectively. See full prescribing information for PERFOROMIST INHALATION SOLUTION. PERFOROMIST ® (formoterol fumarate) Inhalation Solution Initial U.S. Approval: 2001Product nameMylan Specialty L.P.2019-05-01
ForadilProduct namePhysicians Total Care, Inc.2012-03-01