Data updated: Mar 10, 2026
LAMIVUDINE AND ZIDOVUDINE
LAMIVUDINE
Approved 2011-05-25
12
Indications
--
Phase 3 Trials
1
Priority Reviews
14
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2011-05-25
- Routes
- ORAL
- Dosage Forms
- TABLET
LAMIVUDINE AND ZIDOVUDINE Approval History
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What LAMIVUDINE AND ZIDOVUDINE Treats
12 FDA approvalsOriginally approved for its first indication in 2011 . Covers 12 distinct patient populations.
- Other (12)
Other
(12 approvals)- • Approved indication (May 2011)
- • Approved indication (May 2012)
- • Approved indication (Feb 2014)
- • Approved indication (Aug 2014)Letter
- • Approved indication (May 2015)
- • Approved indication (Sep 2015)Letter
- • Approved indication (Mar 2017) PriorityLabel Letter
- • Approved indication (May 2017)Letter
- • Approved indication (Apr 2018)
- • Approved indication (Aug 2018)
- • Approved indication (Sep 2018)Letter
- • Approved indication (Aug 2019)Letter
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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.
LAMIVUDINE AND ZIDOVUDINE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.