Data updated: Mar 10, 2026
AMLODIPINE BESYLATE
AMLODIPINE BESYLATE
Approved 2005-10-03
35
Indications
--
Phase 3 Trials
20
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2005-10-03
- Routes
- ORAL
- Dosage Forms
- TABLET, TABLET, ORALLY DISINTEGRATING
Companies
GEDEON RICHTER USA Hikma Aurobindo Pharma TORRENT PHARMS CHINA RESOURCES UNICHEM INVAGEN PHARMS PURACAP PHARM SOVEREIGN PHARMS PURACAP LABS BLU Teva CHARTWELL RX Sun Pharma EPIC PHARMA LLC Cipla ORBION PHARMS SUNSHINE Viatris ZYDUS PHARMS USA AMNEAL PHARMS NY GRAVITI PHARMS COREPHARMA PHARMOBEDIENT ALKEM SYNTHON PHARMS Lupin OXFORD PHARMS WOCKHARDT STRIDES PHARMA GENPHARM WATSON LABS SCIEGEN PHARMS ACCORD HLTHCARE
Active Ingredient: AMLODIPINE BESYLATE
Website: ↗
AMLODIPINE BESYLATE Approval History
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What AMLODIPINE BESYLATE Treats
35 FDA approvalsOriginally approved for its first indication in 2005 . Covers 35 distinct patient populations.
- Other (35)
Other
(35 approvals)- • Approved indication (Oct 2005)
- • Approved indication (May 2007)
- • Approved indication (Jun 2007)
- • Approved indication (Jun 2007)
- • Approved indication (Jul 2007)
- • Approved indication (Jul 2007)
- • Approved indication (Jul 2007)
- • Approved indication (Jul 2007)
- • Approved indication (Jul 2007)
- • Approved indication (Jul 2007)
- • Approved indication (Aug 2007)
- • Approved indication (Sep 2007)Letter
- • Approved indication (Sep 2007)
- • Approved indication (Sep 2007)
- • Approved indication (Sep 2007)
- • Approved indication (Sep 2007)Label Letter
- • Approved indication (Nov 2007)
- • Approved indication (Jan 2008)
- • Approved indication (Jan 2008)
- • Approved indication (Feb 2008)
- • Approved indication (Sep 2008)
- • Approved indication (Apr 2009)
- • Approved indication (May 2009)
- • Approved indication (Jul 2009)
- • Approved indication (Apr 2010)
- • Approved indication (Apr 2011)
- • Approved indication (Apr 2011)
- • Approved indication (Apr 2012)
- • Approved indication (Apr 2013)
- • Approved indication (Oct 2013)
- • Approved indication (Jul 2015)Letter
- • Approved indication (Dec 2015)Letter
- • Approved indication (Jul 2016)
- • Approved indication (May 2018)
- • Approved indication (Jan 2026) 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.
AMLODIPINE BESYLATE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.