Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate
This is a prescription medication containing a mix of dextroamphetamine and amphetamine salts in extended-release capsules, used to treat attention deficit hyperactivity disorder (ADHD). It's a controlled substance (Schedule CII) taken orally, available in strengths like 1.25mg to 7.5mg per component. Manufactured by Elite Laboratories, Inc. This information was generated using AI and is provided for informational and research purposes only.
Complete Metadata
| @type | dcat:Dataset |
|---|---|
| accessLevel | public |
| accrualPeriodicity | R/P1Y |
| bureauCode |
[
"009:10"
]
|
| contactPoint |
{
"fn": "Division of Drug Information",
"@type": "vcard:Contact",
"hasEmail": "mailto:druginfo@fda.hhs.gov"
}
|
| description | This is a prescription medication containing a mix of dextroamphetamine and amphetamine salts in extended-release capsules, used to treat attention deficit hyperactivity disorder (ADHD). It's a controlled substance (Schedule CII) taken orally, available in strengths like 1.25mg to 7.5mg per component. Manufactured by Elite Laboratories, Inc. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[
{
"@type": "dcat:Distribution",
"title": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate",
"mediaType": "text/html",
"description": "
Access the FDA dataset for Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate — ANDA 021303 submitted by Mylan Institutional LLC
",
"downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021303"
}
]
|
| identifier | ANDA021303 |
| issued | 2016-09-16 |
| keyword |
[
"fda",
"health-care",
"medications",
"prescription-drugs",
"public-health"
]
|
| landingPage | https://www.fda.gov/drugs |
| license | https://open.fda.gov/license |
| modified | 2025-03-17 |
| programCode |
[
"009:002"
]
|
| publisher |
{
"name": "U.S. Food and Drug Administration",
"@type": "org:Organization"
}
|
| theme |
[
"FDA"
]
|
| title | Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate |
