TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

EFAVIRENZ

EFAVIRENZ
Approved 2016-02-17
Jump to: Indications Approvals Trials Competitors Safety Patents
9
Indications
--
Phase 3 Trials
10
Years on Market

Details

Status
None (Tentative Approval)
First Approved
2016-02-17
Routes
ORAL
Dosage Forms
TABLET, CAPSULE

Companies

PAR FORMULATIONS PRIVATE LTD Cipla MICRO LABS LTD INDIA MATRIX LABS HETERO LABS LTD III Aurobindo Pharma MATRIX LABS LTD MICRO LABS LTD Teva Viatris PHARMOBEDIENT EMCURE PHARMA MACLEODS PHARMS LTD PHARMACARE LTD STRIDES PHARMA
Active Ingredient: EFAVIRENZ

EFAVIRENZ Approval History

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What EFAVIRENZ Treats

9 FDA approvals

Originally approved for its first indication in 2016 . Covers 9 distinct patient populations.

  • Other (9)
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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.

EFAVIRENZ FDA Label Details

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Data Sources

FDA Approval: ANDA202990 → Trials: ClinicalTrials.gov →

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