Cocaine hydrochloride
GOPRELTO is a prescription nasal solution containing 4% cocaine hydrochloride (equivalent to 40 mg/mL). It is a DEA Schedule II controlled substance, manufactured by LXO US INC., and approved under NDA209963 for medical use. 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 | GOPRELTO is a prescription nasal solution containing 4% cocaine hydrochloride (equivalent to 40 mg/mL). It is a DEA Schedule II controlled substance, manufactured by LXO US INC., and approved under NDA209963 for medical use. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[
{
"@type": "dcat:Distribution",
"title": "Cocaine hydrochloride",
"mediaType": "text/html",
"description": "
Access the FDA dataset for Cocaine hydrochloride — ANDA 209575 submitted by Mylan Institutional LLC
",
"downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209575"
}
]
|
| identifier | ANDA209575 |
| issued | 2016-09-16 |
| keyword |
[
"drug",
"drug-information",
"health-care",
"medications",
"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 | Cocaine hydrochloride |
