ANDA (Abbreviated New Drug Application)
GPTKB entity
Statements (28)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
submission
FDA application |
| gptkbp:appliesTo |
small molecule drugs
|
| gptkbp:compatibleWith |
biologics
medical devices over-the-counter drugs human clinical trials clinical data animal studies preclinical data |
| gptkbp:contrastsWith |
NDA (New Drug Application)
|
| gptkbp:enables |
generic drug competition
|
| gptkbp:establishedBy |
gptkb:Hatch-Waxman_Act
|
| gptkbp:fullName |
gptkb:Abbreviated_New_Drug_Application
|
| https://www.w3.org/2000/01/rdf-schema#label |
ANDA (Abbreviated New Drug Application)
|
| gptkbp:purpose |
approval of generic drugs
|
| gptkbp:regulates |
generic drug approval
|
| gptkbp:requires |
manufacturing data
labeling information patent certification bioequivalence data chemistry data controls data |
| gptkbp:reviewedBy |
FDA Office of Generic Drugs
|
| gptkbp:usedFor |
market entry of generics
|
| gptkbp:YouTubeChannel |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:bfsParent |
gptkb:U.S._Food_and_Drug_Administration_(FDA)
|
| gptkbp:bfsLayer |
7
|