TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

NEVIRAPINE

NEVIRAPINE
Approved 2012-05-22
Jump to: Indications Approvals Trials Competitors Safety Patents
13
Indications
--
Phase 3 Trials
13
Years on Market

Details

Status
Discontinued
First Approved
2012-05-22
Routes
ORAL
Dosage Forms
TABLET, TABLET, EXTENDED RELEASE, TABLET, FOR SUSPENSION, SUSPENSION

Companies

PRINSTON INC Novartis Aurobindo Pharma EMCURE PHARMA Viatris Cipla Apotex PHARMOBEDIENT RANBAXY HETERO LABS LTD III MICRO LABS LTD STRIDES PHARMA MACLEODS PHARMS LTD TECH ORGANIZED ALVOGEN
Active Ingredient: NEVIRAPINE

NEVIRAPINE Approval History

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What NEVIRAPINE 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.

NEVIRAPINE FDA Label Details

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Data Sources

FDA Approval: ANDA078644 → Trials: ClinicalTrials.gov →

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