ALBUTEROL SULFATE
Details
- Status
- Prescription
- First Approved
- 1989-01-30
- Routes
- ORAL, INHALATION
- Dosage Forms
- SYRUP, TABLET, EXTENDED RELEASE, SOLUTION, TABLET, AEROSOL, METERED
Companies
ALBUTEROL SULFATE Approval History
What ALBUTEROL SULFATE Treats
58 FDA approvalsOriginally approved for its first indication in 1989 . Covers 58 distinct patient populations.
- Other (58)
Other
(58 approvals)- • Approved indication (Jan 1989)
- • Approved indication (Feb 1989)
- • Approved indication (Mar 1989)
- • Approved indication (Apr 1989)
- • Approved indication (Dec 1989)
- • Approved indication (Mar 1990)
- • Approved indication (Jan 1991)
- • Approved indication (Jan 1991)
- • Approved indication (Aug 1991)
- • Approved indication (Feb 1992)
- • Approved indication (Mar 1992)
- • Approved indication (Jun 1993)
- • Approved indication (Sep 1994)
- • Approved indication (Sep 1995)
- • Approved indication (Sep 1995)
- • Approved indication (Sep 1997)
- • Approved indication (Jan 1998)
- • Approved indication (Jan 1998)
- • Approved indication (Jun 1998)Letter
- • Approved indication (Feb 1999)Letter
- • Approved indication (Mar 1999)Letter
- • Approved indication (Nov 1999)Letter
- • Approved indication (Nov 1999)Letter
- • Approved indication (Mar 2000)Label Letter
- • Approved indication (Feb 2001)Letter
- • Approved indication (Jun 2001)Letter
- • Approved indication (Apr 2003)
- • Approved indication (Nov 2003)
- • Approved indication (Jun 2004)
- • Approved indication (Apr 2006)
- • Approved indication (Dec 2006)
- • Approved indication (Jan 2007)
- • Approved indication (Feb 2007)
- • Approved indication (Jun 2007)
- • Approved indication (Sep 2007)
- • Approved indication (Dec 2008)
- • Approved indication (Apr 2010)
- • Approved indication (May 2010)
- • Approved indication (Jul 2017)
- • Approved indication (Oct 2017)
- • Approved indication (May 2018)
- • Approved indication (Jun 2018)
- • Approved indication (Oct 2018)
- • Approved indication (Mar 2019)
- • Approved indication (Sep 2019)
- • Approved indication (Feb 2020)Letter
- • Approved indication (Apr 2020)Letter
- • Approved indication (Apr 2020)
- • Approved indication (May 2020)
- • Approved indication (Aug 2020)
- • Approved indication (Oct 2020)
- • Approved indication (Oct 2020)
- • Approved indication (Jun 2021)
- • Approved indication (Dec 2021)
- • Approved indication (May 2024)
- • Approved indication (May 2024)
- • Approved indication (Mar 2025) New
- • Approved indication (Dec 2025) New
ALBUTEROL SULFATE Competitors
Pro8 other drugs also target beta 2-adrenergic receptor. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (beta 2-adrenergic receptor). Earlier expiry dates signal biosimilar/generic opportunities.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ALBUTEROL SULFATE FDA Label Details
ProIndications & Usage
FDA Label (PDF)Albuterol inhalation solution is indicated for the relief of bronchospasm in patients 2 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm.
Want competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.