TheraRadar
Data updated: May 26, 2026

ASENDIN (amoxapine)

CNS Approved 1980-09-22
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
45
Years on Market

Details

Status
Discontinued
First Approved
1980-09-22
Routes
ORAL
Dosage Forms
TABLET

Companies

LEDERLE
Active Ingredient: AMOXAPINE

ASENDIN Approval History

1981
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Original
New Indication
New Form
Label Update
148 FDA actions from 1980 to 2001
Sep 2001 SUPPL
Label · Labeling
Apr 2000 SUPPL
Label · Labeling
Mar 1999 SUPPL
Mfg · Manufacturing (CMC)

What ASENDIN Treats

1 FDA approvals

Originally approved for its first indication in 1980 .

  • Other (1)
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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.

ASENDIN FDA Label Details

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Data Sources

FDA Approval: NDA018021 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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