TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

ZIDOVUDINE

ZIDOVUDINE
Approved 2005-09-19
Jump to: Indications Approvals Trials Competitors Safety Patents
12
Indications
--
Phase 3 Trials
20
Years on Market

Details

Status
Discontinued
First Approved
2005-09-19
Routes
ORAL, INJECTION
Dosage Forms
TABLET, INJECTABLE, CAPSULE, SOLUTION

Companies

PHARMOBEDIENT Aurobindo Pharma Hikma AM REGENT Cipla RANBAXY LABS LTD HEC PHARM HETERO LABS LTD III LIAONING CHENGDA Teva
Active Ingredient: ZIDOVUDINE

ZIDOVUDINE Approval History

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What ZIDOVUDINE Treats

12 FDA approvals

Originally approved for its first indication in 2005 . Covers 12 distinct patient populations.

  • Other (12)
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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.

ZIDOVUDINE FDA Label Details

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Data Sources

FDA Approval: NDA200732 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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