TheraRadar
Data updated: May 26, 2026

DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE (amphetamine aspartate)

CNS Approved 2002-02-11
Jump to: Indications Approvals Trials Competitors Safety Patents
40
Indications
--
Phase 3 Trials
24
Years on Market

Details

Status
Discontinued
First Approved
2002-02-11
Routes
ORAL
Dosage Forms
CAPSULE, EXTENDED RELEASE, TABLET

Companies

Teva LANNETT CO INC Sun Pharma PH HEALTH COREPHARMA AUROLIFE PHARMA LLC NESHER PHARMS SPECGX LLC ELITE LABS INC GRANULES RHODES PHARMS ASCENT PHARMS INC Novartis EPIC PHARMA LLC ORYZA ACCORD HLTHCARE ALKEM LABS LTD CEDIPROF INC Lupin IMPAX LABS ANI PHARMS ZYDUS PHARMS ALVOGEN NUVO PHARM
Active Ingredient: AMPHETAMINE ASPARTATE , AMPHETAMINE SULFATE , DEXTROAMPHETAMINE SACCHARATE , DEXTROAMPHETAMINE SULFATE

DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE Approval History

2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1102 FDA actions from 2002 to 2026
Apr 2026 SUPPL
Label · Labeling
Jun 2025 SUPPL
Label · Labeling
Mar 2025 SUPPL
Label · Labeling

What DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE Treats

40 FDA approvals

Originally approved for its first indication in 2002 . Covers 40 distinct patient populations.

  • Other (40)
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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT03659929 results posted AR19.004 Ph 3 completed Adult Attention Deficit Hyperactivity Disorder (ADHD) Study With Amphetamine Sulfate
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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.

DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE FDA Label Details

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Data Sources

FDA Approval: ANDA076536 → Trials: ClinicalTrials.gov →

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