Buprenorphine and naloxone
Buprenorphine and Naloxone is a prescription film medication used to treat opioid dependence. It combines buprenorphine (a partial opioid agonist) and naloxone (an opioid antagonist) to help reduce withdrawal symptoms and cravings. Available in buccal or sublingual forms with strengths like 2mg/0.5mg, 4mg/1mg, 8mg/2mg, and 12mg/3mg buprenorphine/naloxone. It's a Schedule III controlled substance. 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 | Buprenorphine and Naloxone is a prescription film medication used to treat opioid dependence. It combines buprenorphine (a partial opioid agonist) and naloxone (an opioid antagonist) to help reduce withdrawal symptoms and cravings. Available in buccal or sublingual forms with strengths like 2mg/0.5mg, 4mg/1mg, 8mg/2mg, and 12mg/3mg buprenorphine/naloxone. It's a Schedule III controlled substance. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[
{
"@type": "dcat:Distribution",
"title": "Buprenorphine and naloxone",
"mediaType": "text/html",
"description": "
Access the FDA dataset for Buprenorphine and naloxone — ANDA 212756 submitted by Mylan Institutional LLC
",
"downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212756"
}
]
|
| identifier | ANDA212756 |
| issued | 2016-09-16 |
| keyword |
[
"drug-manufacturers",
"drug-safety",
"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 | Buprenorphine and naloxone |
