Data updated: Mar 10, 2026
VALGANCICLOVIR HYDROCHLORIDE
VALGANCICLOVIR HYDROCHLORIDE
Approved 2014-11-04
16
Indications
--
Phase 3 Trials
11
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2014-11-04
- Routes
- ORAL
- Dosage Forms
- TABLET, FOR SOLUTION
Companies
Cipla Aurobindo Pharma STRIDES PHARMA INTL PHARMOBEDIENT Dr. Reddy's GRANULES AJANTA PHARMA LTD HETERO LABS LTD V Teva APPCO SPH ZHONGXI PHARM MSN SOMERSET THERAPS LLC
Active Ingredient: VALGANCICLOVIR HYDROCHLORIDE
Website: ↗
VALGANCICLOVIR HYDROCHLORIDE Approval History
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What VALGANCICLOVIR HYDROCHLORIDE Treats
16 FDA approvalsOriginally approved for its first indication in 2014 . Covers 16 distinct patient populations.
- Other (16)
Other
(16 approvals)- • Approved indication (Nov 2014)Letter
- • Approved indication (Mar 2016)
- • Approved indication (Mar 2016)
- • Approved indication (Jul 2016)Letter
- • Approved indication (Dec 2017)
- • Approved indication (Nov 2018)
- • Approved indication (Dec 2019)
- • Approved indication (Jan 2020)
- • Approved indication (Jan 2020)
- • Approved indication (Mar 2021)
- • Approved indication (Feb 2022)
- • Approved indication (Oct 2022)
- • Approved indication (Nov 2022)
- • Approved indication (Apr 2023)
- • Approved indication (Jun 2024)
- • Approved indication (Apr 2025) New
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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.
VALGANCICLOVIR HYDROCHLORIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.