TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

TEMAZEPAM

TEMAZEPAM
Approved 1986-07-10
Jump to: Indications Approvals Trials Competitors Safety Patents
13
Indications
--
Phase 3 Trials
39
Years on Market

Details

Status
Discontinued
First Approved
1986-07-10
Routes
ORAL
Dosage Forms
CAPSULE

Companies

USL PHARMA WATSON LABS NOVEL LABS INC ALEMBIC Sun Pharma Teva CHARTWELL RX PRINSTON INC ALKEM LABS LTD DURAMED PHARMS BARR Aurobindo Pharma AMNEAL PHARMS
Active Ingredient: TEMAZEPAM

TEMAZEPAM Approval History

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What TEMAZEPAM Treats

13 FDA approvals

Originally approved for its first indication in 1986 . 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.

TEMAZEPAM FDA Label Details

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Data Sources

FDA Approval: ANDA070489 → Trials: ClinicalTrials.gov →

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