Emtricitabine and tenofovir disoproxil fumarate
Emtricitabine and Tenofovir Disoproxil Fumarate is a generic prescription tablet combining two antiviral medications to treat HIV infection by blocking the virus from multiplying in the body. Each tablet contains 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate, taken orally once daily. Manufactured by Aurobindo Pharma Limited, it's approved as an ANDA drug. 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 | Emtricitabine and Tenofovir Disoproxil Fumarate is a generic prescription tablet combining two antiviral medications to treat HIV infection by blocking the virus from multiplying in the body. Each tablet contains 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate, taken orally once daily. Manufactured by Aurobindo Pharma Limited, it's approved as an ANDA drug. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[
{
"@type": "dcat:Distribution",
"title": "Emtricitabine and tenofovir disoproxil fumarate",
"mediaType": "text/html",
"description": "
Access the FDA dataset for Emtricitabine and tenofovir disoproxil fumarate — ANDA 213541 submitted by Mylan Institutional LLC
",
"downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213541"
}
]
|
| identifier | ANDA213541 |
| issued | 2016-09-16 |
| keyword |
[
"drug",
"drug-manufacturers",
"drug-safety",
"fda",
"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 | Emtricitabine and tenofovir disoproxil fumarate |