Dactinomycin
Dactinomycin is a prescription injectable drug, available as a lyophilized powder for intravenous use. Manufactured by Meitheal Pharmaceuticals Inc., it contains 0.5 mg of dactinomycin per vial and belongs to the actinomycin class, acting as an inhibitor of nucleic acid and protein synthesis. This generic version (ANDA213463) is used in medical treatments and was approved for marketing in November 2020. 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 | Dactinomycin is a prescription injectable drug, available as a lyophilized powder for intravenous use. Manufactured by Meitheal Pharmaceuticals Inc., it contains 0.5 mg of dactinomycin per vial and belongs to the actinomycin class, acting as an inhibitor of nucleic acid and protein synthesis. This generic version (ANDA213463) is used in medical treatments and was approved for marketing in November 2020. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[
{
"@type": "dcat:Distribution",
"title": "Dactinomycin",
"mediaType": "text/html",
"description": "
Access the FDA dataset for Dactinomycin — ANDA 203999 submitted by Mylan Institutional LLC
",
"downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203999"
}
]
|
| identifier | ANDA203999 |
| issued | 2016-09-16 |
| keyword |
[
"drug",
"drug-manufacturers",
"fda",
"medications",
"prescription-drugs"
]
|
| 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 | Dactinomycin |
