Approved Drug Products with Therapuetic Equivalence Evaluations (Orange Book)
The publication Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book) identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act). (For more information, see the Orange Book Preface.)
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Complete Metadata
| @type | dcat:Dataset |
|---|---|
| accessLevel | public |
| bureauCode |
[
"009:10"
]
|
| contactPoint |
{
"fn": "openFDA",
"@type": "vcard:Contact",
"hasEmail": "mailto:open@fda.hhs.gov"
}
|
| description | The publication Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book) identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act). (For more information, see the Orange Book Preface.) |
| distribution |
[
{
"@type": "dcat:Distribution",
"mediaType": "application/zip",
"downloadURL": "http://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM163762.zip"
}
]
|
| identifier | c7b84420-8e01-44eb-92de-c5e7f975ab28 |
| issued | 2021-02-25 |
| keyword |
[
"cder",
"orange book"
]
|
| landingPage | http://www.fda.gov/Drugs/InformationOnDrugs/ucm129662.htm |
| license | http://opendefinition.org/licenses/odc-odbl/ |
| modified | 2013-10-31 |
| programCode |
[
"009:002"
]
|
| publisher |
{
"name": "U.S. Food and Drug Administration",
"@type": "org:Organization"
}
|
| references |
[
"http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm"
]
|
| theme |
[
"FDA"
]
|
| title | Approved Drug Products with Therapuetic Equivalence Evaluations (Orange Book) |
