Data updated: Mar 10, 2026
DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE
AMPHETAMINE ASPARTATE
Approved 2002-02-11
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 AUROLIFE PHARMA LLC GRANULES Novartis Sun Pharma LANNETT CO INC SPECGX LLC COREPHARMA ALVOGEN NUVO PHARM EPIC PHARMA LLC IMPAX LABS CEDIPROF INC RHODES PHARMS ASCENT PHARMS INC Lupin ZYDUS PHARMS ELITE LABS INC PH HEALTH ORYZA ALKEM LABS LTD ANI PHARMS NESHER PHARMS ACCORD HLTHCARE
Active Ingredient: AMPHETAMINE ASPARTATE , AMPHETAMINE SULFATE , DEXTROAMPHETAMINE SACCHARATE , DEXTROAMPHETAMINE SULFATE
Website: ↗
DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE Approval History
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What DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE Treats
40 FDA approvalsOriginally approved for its first indication in 2002 . Covers 40 distinct patient populations.
- Other (40)
Other
(40 approvals)- • Approved indication (Feb 2002)
- • Approved indication (Jun 2002)Letter
- • Approved indication (Jun 2002)Letter
- • Approved indication (May 2003)
- • Approved indication (Sep 2003)
- • Approved indication (Sep 2003)
- • Approved indication (Oct 2003)
- • Approved indication (Jun 2012)Letter
- • Approved indication (Feb 2013)
- • Approved indication (Apr 2013)
- • Approved indication (Nov 2013)
- • Approved indication (Nov 2015)
- • Approved indication (Feb 2016)
- • Approved indication (Feb 2016)
- • Approved indication (Jul 2017)
- • Approved indication (Oct 2017)
- • Approved indication (Dec 2017)
- • Approved indication (Dec 2018)
- • Approved indication (Jan 2019)
- • Approved indication (Apr 2019)
- • Approved indication (May 2019)
- • Approved indication (May 2019)
- • Approved indication (Jul 2019)
- • Approved indication (Dec 2019)
- • Approved indication (Apr 2020)
- • Approved indication (Jun 2020)
- • Approved indication (Jan 2021)
- • Approved indication (Apr 2021)
- • Approved indication (Sep 2021)
- • Approved indication (Nov 2021)
- • Approved indication (Nov 2021)
- • Approved indication (Dec 2021)
- • Approved indication (Jan 2022)Letter
- • Approved indication (Jul 2022)
- • Approved indication (Jul 2022)
- • Approved indication (Jan 2023)
- • Approved indication (Aug 2023)
- • Approved indication (Sep 2023)
- • Approved indication (Oct 2023)
- • Approved indication (Nov 2024)
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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
Data sourced from official FDA and NIH databases. Click links to verify on original sources.