Data updated: Mar 10, 2026
MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETIL
Approved 2008-07-29
29
Indications
--
Phase 3 Trials
17
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2008-07-29
- Routes
- ORAL
- Dosage Forms
- CAPSULE, FOR SUSPENSION, TABLET
Companies
STRIDES PHARMA INTL CONCORD BIOTECH LTD RISING Aurobindo Pharma Novartis ACCORD HLTHCARE Apotex VISTAPHARM LLC Teva ZYDUS PHARMS USA INC AMNEAL ALKEM LABS LTD ZHEJIANG HISUN PHARM Dr. Reddy's WUXI LANNETT CO INC HETERO LABS LTD V STRIDES PHARMA Viatris Hikma JUBILANT CADISTA
Active Ingredient: MYCOPHENOLATE MOFETIL
Website: ↗
MYCOPHENOLATE MOFETIL Approval History
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What MYCOPHENOLATE MOFETIL Treats
29 FDA approvalsOriginally approved for its first indication in 2008 . Covers 29 distinct patient populations.
- Other (29)
Other
(29 approvals)- • Approved indication (Jul 2008)Label Letter
- • Approved indication (Oct 2008)
- • Approved indication (Apr 2009)
- • Approved indication (May 2009)
- • Approved indication (May 2009)
- • Approved indication (Dec 2009)
- • Approved indication (Jun 2010)
- • Approved indication (Jul 2010)
- • Approved indication (Sep 2010)
- • Approved indication (Oct 2011)
- • Approved indication (Nov 2011)
- • Approved indication (Jun 2013)
- • Approved indication (Nov 2014)
- • Approved indication (Dec 2014)
- • Approved indication (Nov 2017)
- • Approved indication (Nov 2017)
- • Approved indication (Jan 2019)
- • Approved indication (Feb 2019)
- • Approved indication (Jul 2020)
- • Approved indication (Jul 2021)
- • Approved indication (Nov 2021)
- • Approved indication (Jan 2022)
- • Approved indication (Aug 2023)
- • Approved indication (Sep 2023)
- • Approved indication (Jan 2024)
- • Approved indication (Feb 2024)
- • Approved indication (Sep 2024)
- • Approved indication (Oct 2024)
- • Approved indication (Nov 2024)
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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.
MYCOPHENOLATE MOFETIL FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.