Data updated: Mar 10, 2026
SILDENAFIL CITRATE
SILDENAFIL CITRATE
Approved 2012-11-06
41
Indications
--
Phase 3 Trials
13
Years on Market
Details
- Status
- None (Tentative Approval)
- First Approved
- 2012-11-06
- Routes
- ORAL, INTRAVENOUS
- Dosage Forms
- TABLET, SOLUTION, FOR SUSPENSION
Companies
Apotex HETERO LABS LTD V CHARTWELL RX CADILA PHARMS LTD Teva AMNEAL PHARMS Aurobindo Pharma EUGIA PHARMA TRIS PHARMA INC SUNSHINE WATSON LABS INC RUBICON RESEARCH REYOUNG TARO TORRENT JUBILANT GENERICS Viatris AMNEAL PHARMS NY UMEDICA AJANTA PHARMA LTD MSN MACLEODS PHARMS LTD Dr. Reddy's ZYDUS LIFESCIENCES INVAGEN PHARMS PERRIGO R AND D APPCO Lupin NOVITIUM PHARMA ALKEM LABS LTD GRANULES TORRENT PHARMS LTD
Active Ingredient: SILDENAFIL CITRATE
Website: ↗
SILDENAFIL CITRATE Approval History
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What SILDENAFIL CITRATE Treats
41 FDA approvalsOriginally approved for its first indication in 2012 . Covers 41 distinct patient populations.
- Other (41)
Other
(41 approvals)- • Approved indication (Nov 2012)Letter
- • Approved indication (Nov 2012)
- • Approved indication (Jan 2013)Letter
- • Approved indication (Feb 2013)
- • Approved indication (Feb 2013)
- • Approved indication (Dec 2013)
- • Approved indication (Nov 2014)
- • Approved indication (Apr 2015)
- • Approved indication (Nov 2015)
- • Approved indication (Mar 2016)Letter
- • Approved indication (Jun 2016)
- • Approved indication (May 2018)
- • Approved indication (Jun 2018)
- • Approved indication (Jun 2018)
- • Approved indication (Oct 2018)
- • Approved indication (Mar 2019)
- • Approved indication (Mar 2019)
- • Approved indication (May 2019)Letter
- • Approved indication (Nov 2019)
- • Approved indication (Mar 2020)
- • Approved indication (Apr 2020)
- • Approved indication (May 2020)Letter
- • Approved indication (Jun 2020)
- • Approved indication (Jun 2020)
- • Approved indication (Aug 2020)
- • Approved indication (Aug 2020)
- • Approved indication (Nov 2020)
- • Approved indication (Apr 2021)
- • Approved indication (May 2021)
- • Approved indication (Nov 2021)
- • Approved indication (Nov 2021)
- • Approved indication (Feb 2022)
- • Approved indication (Mar 2022)
- • Approved indication (Sep 2022)
- • Approved indication (Dec 2022)
- • Approved indication (Apr 2023)
- • Approved indication (Aug 2023)
- • Approved indication (Nov 2023)
- • Approved indication (Dec 2023)
- • Approved indication (Dec 2024)
- • Approved indication (Mar 2025)
🔬
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.
SILDENAFIL CITRATE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.