PANTOPRAZOLE SODIUM
Details
- Status
- Prescription
- First Approved
- 2007-08-02
- Routes
- ORAL, INTRAVENOUS, INJECTION
- Dosage Forms
- TABLET, DELAYED RELEASE, INJECTABLE, FOR SUSPENSION, DELAYED RELEASE, POWDER
Companies
PANTOPRAZOLE SODIUM Approval History
What PANTOPRAZOLE SODIUM Treats
34 FDA approvalsOriginally approved for its first indication in 2007 . Covers 34 distinct patient populations.
- Other (34)
Other
(34 approvals)- • Approved indication (Aug 2007)Letter
- • Approved indication (Sep 2007)
- • Approved indication (Jan 2011)
- • Approved indication (Jan 2011)
- • Approved indication (Feb 2011)
- • Approved indication (Aug 2011)
- • Approved indication (Feb 2012)
- • Approved indication (May 2012)
- • Approved indication (Sep 2012)
- • Approved indication (Nov 2012)
- • Approved indication (May 2014)
- • Approved indication (Sep 2014)
- • Approved indication (Dec 2014)
- • Approved indication (Jul 2015)
- • Approved indication (Jan 2016)
- • Approved indication (Mar 2016)
- • Approved indication (Jun 2017)Label Letter
- • Approved indication (May 2018)
- • Approved indication (Mar 2019)
- • Approved indication (Aug 2019)
- • Approved indication (Jun 2020)Letter
- • Approved indication (Aug 2021)
- • Approved indication (May 2022)
- • Approved indication (May 2022)
- • Approved indication (Jul 2022)
- • Approved indication (Aug 2022)
- • Approved indication (Feb 2023)
- • Approved indication (Jun 2023)
- • Approved indication (Oct 2023)
- • Approved indication (Dec 2023)
- • Approved indication (Aug 2024)
- • Approved indication (Jan 2025)
- • Approved indication (Mar 2025) New
- • Approved indication (May 2025) New
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.
PANTOPRAZOLE SODIUM FDA Label Details
ProIndications & Usage
FDA Label (PDF)Pantoprazole Sodium for Injection is indicated for treatment of: gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults. Limitations of Use The safety and effectiveness of Pantoprazole Sodium for Injection for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients. Pediatric use information is approved for Pfizer Inc.'s PROTONIX® I.V. (pantoprazole sodium) for Injection. However, due to Pfizer Inc.'s...
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.