Abbreviated New Drug Application (ANDA)
GPTKB entity
Statements (27)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
submission
FDA application |
| gptkbp:administeredBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:appliesTo |
generic drug manufacturers
|
| gptkbp:compatibleWith |
clinical data
animal studies preclinical data new clinical trials |
| gptkbp:contrastsWith |
New Drug Application (NDA)
|
| gptkbp:enables |
marketing of generic drugs
|
| gptkbp:filingDate |
pharmaceutical companies
|
| https://www.w3.org/2000/01/rdf-schema#label |
Abbreviated New Drug Application (ANDA)
|
| gptkbp:legalBasis |
gptkb:Hatch-Waxman_Act
|
| gptkbp:purpose |
approval of generic drugs
|
| gptkbp:regulates |
Center for Drug Evaluation and Research
|
| gptkbp:relatedTo |
generic drug approval process
|
| gptkbp:requires |
manufacturing data
labeling information bioequivalence studies chemistry data controls data bioavailability data |
| gptkbp:shortName |
gptkb:ANDA
|
| gptkbp:usedIn |
gptkb:United_States
|
| gptkbp:bfsParent |
gptkb:New_Drug_Applications_(NDA)
gptkb:21_U.S.C._§_355 |
| gptkbp:bfsLayer |
8
|