TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

MYCOPHENOLATE SODIUM

MYCOPHENOLATE SODIUM
Approved 2012-08-21
Jump to: Indications Approvals Trials Competitors Safety Patents
13
Indications
--
Phase 3 Trials
13
Years on Market

Details

Status
Prescription
First Approved
2012-08-21
Routes
ORAL
Dosage Forms
TABLET, DELAYED RELEASE

Companies

CONCORD BIOTECH LTD Apotex ACCORD HLTHCARE BIOCON PHARMA FOSUN WANBANG Aurobindo Pharma RK PHARMA Teva ALKEM LABS LTD TWI PHARMS YICHANG HUMANWELL
Active Ingredient: MYCOPHENOLATE SODIUM

MYCOPHENOLATE SODIUM Approval History

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What MYCOPHENOLATE SODIUM Treats

13 FDA approvals

Originally approved for its first indication in 2012 . Covers 13 distinct patient populations.

  • Other (13)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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 SODIUM FDA Label Details

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Data Sources

FDA Approval: ANDA211173 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.