Data updated: Mar 10, 2026
APIXABAN
APIXABAN
Approved 2019-12-23
12
Indications
--
Phase 3 Trials
6
Years on Market
Details
- Status
- None (Tentative Approval)
- First Approved
- 2019-12-23
- Routes
- FILM COATED, ORAL
- Dosage Forms
- TABLET
Companies
UNICHEM LABS LTD Sun Pharma Viatris BIONPHARMA HETERO LABS LTD V Dr. Reddy's FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO., PRINSTON PHARMA INC SCIEGEN PHARMACEUTICALS INC MICRO LABS Apotex Teva BRECKENRIDGE REGCON HOLDINGS SUNSHINE LAKE ACCORD HLTHCARE ZYDUS PHARMS IMPAX Aurobindo Pharma SIGMAPHARM LABS LLC MACLEODS PHARMS LTD TORRENT ZHEJIANG YONGNING PHARMACEUTICAL CO LTD
Active Ingredient: APIXABAN
Website: ↗
APIXABAN Approval History
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What APIXABAN Treats
12 FDA approvalsOriginally approved for its first indication in 2019 . Covers 12 distinct patient populations.
- Other (12)
Other
(12 approvals)- • Approved indication (Dec 2019)Letter
- • Approved indication (Apr 2020)
- • Approved indication (Jul 2020)
- • Approved indication (Sep 2020)
- • Approved indication (Jul 2021)Letter
- • Approved indication (Feb 2023)
- • Approved indication (May 2023)Letter
- • Approved indication (Nov 2023)Letter
- • Approved indication (Feb 2024)
- • Approved indication (Dec 2024)
- • Approved indication (Feb 2025)Letter
- • Approved indication (Feb 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.
APIXABAN FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.