Abbreviated New Drug Application
GPTKB entity
Statements (25)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
submission
|
| gptkbp:abbreviation |
gptkb:ANDA
|
| gptkbp:appliesTo |
generic drug
|
| gptkbp:category |
gptkb:drug
|
| gptkbp:compatibleWith |
clinical data
preclinical data |
| gptkbp:country |
gptkb:United_States
|
| gptkbp:enables |
market entry of generic drugs
|
| https://www.w3.org/2000/01/rdf-schema#label |
Abbreviated New Drug Application
|
| gptkbp:introducedIn |
1984
|
| gptkbp:legalBasis |
gptkb:Hatch-Waxman_Act
|
| gptkbp:product |
reference listed drug
|
| gptkbp:purpose |
approval of generic drugs
|
| gptkbp:regulates |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:relatedTo |
gptkb:New_Drug_Application
|
| gptkbp:requires |
manufacturing information
bioequivalence studies chemistry information controls information labeling identical to reference listed drug |
| gptkbp:YouTubeChannel |
gptkb:FDA_Center_for_Drug_Evaluation_and_Research
|
| gptkbp:bfsParent |
gptkb:New_Drug_Application
gptkb:505(j)_pathway gptkb:Hatch-Waxman_Act |
| gptkbp:bfsLayer |
7
|