Data updated: Mar 10, 2026
ZOLEDRONIC ACID
ZOLEDRONIC ACID
Approved 2013-03-04
31
Indications
--
Phase 3 Trials
13
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2013-03-04
- Routes
- INTRAVENOUS, IV (INFUSION), INJECTION
- Dosage Forms
- INJECTABLE, SOLUTION
Companies
SUN PHARMA GLOBAL PHARMAFORCE Dr. Reddy's Pfizer Viatris BRECKENRIDGE EPIC PHARMA LLC Teva AVET LIFESCIENCES Hikma Apotex GLAND EUGIA PHARMA USV Cipla INFORLIFE ACCORD HLTHCARE BPI LABS SAGENT PHARMS INC CHARTWELL RX SHILPA NOVAST LABS MEITHEAL Fresenius Kabi AMNEAL
Active Ingredient: ZOLEDRONIC ACID
Website: ↗
ZOLEDRONIC ACID Approval History
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What ZOLEDRONIC ACID Treats
31 FDA approvalsOriginally approved for its first indication in 2013 . Covers 31 distinct patient populations.
- Other (31)
Other
(31 approvals)- • Approved indication (Mar 2013)
- • Approved indication (Mar 2013)
- • Approved indication (Mar 2013)
- • Approved indication (Apr 2013)
- • Approved indication (May 2013)
- • Approved indication (Jun 2013)
- • Approved indication (Aug 2013)Label Letter
- • Approved indication (Aug 2013)
- • Approved indication (Sep 2013)
- • Approved indication (May 2014)
- • Approved indication (Aug 2014)
- • Approved indication (Sep 2014)
- • Approved indication (Nov 2014)
- • Approved indication (Mar 2015)
- • Approved indication (Apr 2015)Letter
- • Approved indication (Dec 2015)
- • Approved indication (Dec 2015)Label Letter
- • Approved indication (Aug 2016)
- • Approved indication (Sep 2016)
- • Approved indication (Nov 2016)
- • Approved indication (Feb 2017)
- • Approved indication (Oct 2017)
- • Approved indication (Dec 2017)
- • Approved indication (Dec 2017)
- • Approved indication (Jun 2018)
- • Approved indication (Nov 2018)
- • Approved indication (May 2019)
- • Approved indication (Aug 2019)
- • Approved indication (Feb 2020)
- • Approved indication (Jun 2023)
- • Approved indication (Feb 2026) New
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
ZOLEDRONIC ACID FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.