Data updated: May 26, 2026
ABACAVIR SULFATE AND LAMIVUDINE (abacavir sulfate)
Infectious Disease
Approved 2015-12-22
7
Indications
--
Phase 3 Trials
10
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2015-12-22
- Routes
- ORAL
- Dosage Forms
- TABLET, TABLET, FOR SUSPENSION
Companies
MACLEODS PHARMS LTD Aurobindo Pharma Teva PHARMOBEDIENT LAURUS ZYDUS PHARMS Cipla CHARTWELL RX HETERO LABS LTD V
Website: ↗
ABACAVIR SULFATE AND LAMIVUDINE Approval History
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
29 FDA actions from 2015 to 2025
Dec 2024 ORIGINAL
Update
Jun 2024 SUPPL
Label · Labeling
Jun 2023 SUPPL
Label
Jun 2023 SUPPL
Label
Apr 2023 SUPPL
Label
Jul 2022 ORIGINAL
Update
Nov 2020 SUPPL
Label
May 2020 SUPPL
Label
Feb 2020 SUPPL
Label
Jan 2020 SUPPL
Label
Jul 2019 SUPPL
Label
Jul 2019 SUPPL
Label
Nov 2018 ORIGINAL
Update
Mar 2017 ORIGINAL
Update
Dec 2015 SUPPL
Label
What ABACAVIR SULFATE AND LAMIVUDINE Treats
7 FDA approvalsOriginally approved for its first indication in 2016 . Covers 7 distinct patient populations.
- Other (7)
🔬
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.
ABACAVIR SULFATE AND LAMIVUDINE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.