Data updated: Mar 10, 2026
IPRATROPIUM BROMIDE
IPRATROPIUM BROMIDE
Approved 1997-01-10
22
Indications
--
Phase 3 Trials
29
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1997-01-10
- Routes
- INHALATION, NASAL
- Dosage Forms
- SOLUTION, SPRAY, METERED, AEROSOL, METERED
Companies
Sun Pharma PHARMOBEDIENT Apotex Lupin ARMSTRONG PHARMS Hikma AMNEAL RUBICON RESEARCH Teva LANDELA PHARM Aurobindo Pharma NEPHRON WATSON LABS BAUSCH ROXANE RITEDOSE CORP ZENNOVA LUOXIN AUROVITAS
Active Ingredient: IPRATROPIUM BROMIDE
Website: ↗
IPRATROPIUM BROMIDE Approval History
Loading approval history...
What IPRATROPIUM BROMIDE Treats
22 FDA approvalsOriginally approved for its first indication in 1997 . Covers 22 distinct patient populations.
- Other (22)
Other
(22 approvals)- • Approved indication (Jan 1997)
- • Approved indication (Apr 1999)Label Letter
- • Approved indication (Feb 2000)Label Letter
- • Approved indication (Jan 2001)Letter
- • Approved indication (Jan 2001)Letter
- • Approved indication (Mar 2001)Letter
- • Approved indication (Sep 2001)Letter
- • Approved indication (Oct 2001)Letter
- • Approved indication (Jul 2002)
- • Approved indication (Mar 2003)
- • Approved indication (Apr 2003)
- • Approved indication (Nov 2003)
- • Approved indication (May 2005)
- • Approved indication (Jul 2005)
- • Approved indication (Oct 2016)
- • Approved indication (Jan 2017)
- • Approved indication (Aug 2022)
- • Approved indication (Nov 2024)
- • Approved indication (Jan 2025)
- • Approved indication (Jan 2025)
- • Approved indication (Feb 2025)
- • Approved indication (Feb 2026) New
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
Loading...
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.
IPRATROPIUM BROMIDE FDA Label Details
ProWant 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.