Amphetamine aspartate
Adderall, 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
Trade Name
FDA
EMA
Combinations
Adderall, Mydayis (generic drugs available since 2002-02-11)
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 25 | Takeda | N-021303 RX | 2002-05-22 | 1 products, RLD |
| ADDERALL XR 5 | Takeda | N-021303 RX | 2002-05-22 | 1 products, RLD |
| ADDERALL XR 15 | Takeda | N-021303 RX | 2002-05-22 | 1 products, RLD |
| ADDERALL XR 10 | Takeda | N-021303 RX | 2001-10-11 | 1 products, RLD |
| ADDERALL XR 20 | Takeda | N-021303 RX | 2001-10-11 | 1 products, RLD |
| ADDERALL XR 30 | Takeda | N-021303 RX | 2001-10-11 | 1 products, RLD, RS |
| MYDAYIS | Takeda | N-022063 RX | 2017-06-20 | 4 products, RLD, RS |
Show 7 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| adderall | New Drug Application | 2022-10-24 |
| dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate | ANDA | 2023-06-14 |
| mydayis | New Drug Application | 2022-10-28 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| attention deficit disorder with hyperactivity | EFO_0003888 | D001289 | F90 |
| narcolepsy | EFO_0000614 | D009290 | G47.4 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
AMPHETAMINE ASPARTATE / AMPHETAMINE SULFATE / DEXTROAMPHETAMINE SACCHARATE / DEXTROAMPHETAMINE SULFATE, MYDAYIS, TAKEDA PHARMS USA | |||
| 2023-03-13 | PED | ||
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
27 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 hyperactivity | D001289 | EFO_0003888 | F90 | — | 5 | 5 | 2 | — | 10 |
| Cognitive dysfunction | D060825 | G31.84 | — | 1 | 1 | 1 | — | 2 | |
| Motivation | D009042 | — | — | — | 1 | — | 1 | ||
| Deception | D008192 | — | — | — | 1 | — | 1 | ||
| Substance-related disorders | D019966 | EFO_0003890 | F13 | — | — | — | 1 | — | 1 |
| Conduct disorder | D019955 | EFO_0004216 | F91 | — | — | — | 1 | — | 1 |
| Covid-19 | D000086382 | U07.1 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cocaine-related disorders | D019970 | F14 | — | 3 | 2 | — | — | 3 | |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | 2 | 2 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Short-term memory | D008570 | EFO_0004335 | — | 1 | — | — | — | 1 | |
| Affect | D000339 | — | 1 | — | — | — | 1 | ||
| Narcolepsy | D009290 | EFO_0000614 | G47.4 | — | 1 | — | — | — | 1 |
| Idiopathic hypersomnia | D020177 | G47.11 | — | 1 | — | — | — | 1 | |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | 1 | — | — | — | 1 |
| Neoplasms | D009369 | C80 | — | 1 | — | — | — | 1 | |
| Depression | D003863 | F33.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 1 | — | — | — | — | 1 | ||
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 1 | — | — | — | — | 1 |
| Hemodynamics | D006439 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | AMPHETAMINE 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 class | CNS stimulant, anorectic |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CC(N)Cc1ccccc1.NC(CC(=O)O)C(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 300-62-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1200377 |
| ChEBI ID | — |
| PubChem CID | 3007 |
| DrugBank | DB00182 |
| UNII ID | — |
Target
Agency Approved
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Alternate
No data
Variants
Clinical Variant
No data
Financial
Mydayis - Shire
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Adderall - Shire
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Adderall - Takeda
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Trends
PubMed Central
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Additional graphs summarizing 1,572 documents
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Safety
Black-box Warning
Black-box warning for: Adderall, Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate, Mydayis
Adverse Events
Top Adverse Reactions
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11,301 adverse events reported
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