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Drug ReportsAmphetamine dl-aspartate
Amphetamine aspartate
Adderall, Amphetamine / Amphetamine / Dextroamphetamine / Dextroamphetamine, Mydayis (amphetamine aspartate) is a small molecule pharmaceutical. Amphetamine aspartate was first approved as Adderall 10 on 1996-02-13. It is used to treat attention deficit disorder with hyperactivity and narcolepsy in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
mental disordersD001523
Trade Name
FDA
EMA
Combinations
Adderall, Dextroamp saccharate, amp aspartate, dextroamp amp, Dyanavel, Mydayis (discontinued: Adderall, Dextroamp saccharate, amp aspartate, dextroamp amp, Dextroamp saccharate,amp aspartate,dextroamp amp)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amphetamine aspartate
+
Amphetamine sulfate
+
Dextroamphetamine saccharate
+
Dextroamphetamine sulfate
Tradename
Company
Number
Date
Products
ADDERALL XR 10TakedaN-021303 RX2001-10-11
1 products, RLD
ADDERALL XR 20TakedaN-021303 RX2001-10-11
1 products, RLD
ADDERALL XR 30TakedaN-021303 RX2001-10-11
1 products, RLD, RS
ADDERALL XR 25TakedaN-021303 RX2002-05-22
1 products, RLD
ADDERALL XR 5TakedaN-021303 RX2002-05-22
1 products, RLD
ADDERALL XR 15TakedaN-021303 RX2002-05-22
1 products, RLD
MYDAYISTakedaN-022063 RX2017-06-20
4 products, RLD, RS
Show 7 discontinued
Amphetamine
+
Amphetamine aspartate
+
Dextroamphetamine sulfate
Tradename
Company
Number
Date
Products
DYANAVEL XRTris PharmaN-208147 RX2015-10-19
1 products, RLD, RS
DYANAVEL XR 5Tris PharmaN-210526 RX2021-11-04
1 products, RLD
DYANAVEL XR 10Tris PharmaN-210526 RX2021-11-04
1 products, RLD
DYANAVEL XR 15Tris PharmaN-210526 RX2021-11-04
1 products, RLD
DYANAVEL XR 20Tris PharmaN-210526 RX2021-11-04
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
adderallNew Drug Application2025-09-23
adderall xrNew Drug Application2010-03-29
dextroamphetamine saccharate and amphetamine aspartate and dextroamphetamine sulfate and amphetamine sulfateANDA2023-10-20
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfateANDA2025-08-04
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfateANDA2024-02-05
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-releaseANDA2024-02-01
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfateANDA2025-07-18
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-releaseANDA2024-01-12
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine suflate2007-08-02
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine suflateANDA2011-02-01
Show 7 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
narcolepsyEFO_0000614D009290G47.4
attention deficit disorder with hyperactivityEFO_0003888D001289F90
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Amphetamine Aspartate / Amphetamine Sulfate / Dextroamphetamine Saccharate / Dextroamphetamine Sulfate, Mydayis, Takeda Pharms Usa
88461002029-08-24DP
91738572026-05-12U-2025
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
9 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Attention deficit disorder with hyperactivityD001289EFO_0003888F902241—8
Autistic disorderD001321EFO_0003758F84.0———1—1
Autism spectrum disorderD000067877—F84.0———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HyperkinesisD006948——114——6
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DepressionD003863—F33.9—1———1
Bipolar disorderD001714EFO_0000289F30.9—1———1
Depressive disorderD003866EFO_1002014F32.A—1———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAmphetamine aspartate
INN—
Description
1-phenylpropan-2-amine is a primary amine that is isopropylamine in which a hydrogen attached to one of the methyl groups has been replaced by a phenyl group.
Classification
Small molecule
Drug classCNS stimulant, anorectic
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC(N)Cc1ccccc1.NC(CC(=O)O)C(=O)O
Identifiers
PDB—
CAS-ID156-34-3
RxCUI—
ChEMBL IDCHEMBL1200377
ChEBI ID—
PubChem CID3007
DrugBankDB00182
UNII ID—
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Adderall – Shire
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Adderall – Takeda
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Mydayis – Shire
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 55 documents
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Safety
Black-box Warning
Black-box warning for: Adderall, Adderall xr, Dextroamphetamine saccharate and amphetamine aspartate and dextroamphetamine sulfate and amphetamine sulfate, Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate, Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate, Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release, Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate, Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release, Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate, Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate, Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate tablets,cii, Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate, Mixed salts of a single entity amphetamine product, Mixed salts of a single-entity amphetamine product, Mydayis
Adverse Events
Top Adverse Reactions
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16,649 adverse events reported
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