Abbreviated New Drug Applications
GPTKB entity
Statements (33)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory process
|
| gptkbp:abbreviation |
gptkb:ANDA
|
| gptkbp:application |
generic drug manufacturer
|
| gptkbp:appliesTo |
generic drugs
|
| gptkbp:compatibleWith |
brand-name drugs
preclinical data clinical data for safety and efficacy |
| gptkbp:enables |
interchangeability with reference listed drug
market entry of generics |
| gptkbp:establishedBy |
gptkb:Hatch-Waxman_Act
|
| gptkbp:establishedIn |
1984
|
| https://www.w3.org/2000/01/rdf-schema#label |
Abbreviated New Drug Applications
|
| gptkbp:purpose |
approval of generic drugs
|
| gptkbp:regulates |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:relatedTo |
gptkb:New_Drug_Application
gptkb:505(j)_pathway |
| gptkbp:requires |
labeling information
manufacturing information bioequivalence studies chemistry information controls information drug product sameness patent certification same active ingredient same dosage form same labeling (with permissible differences) same route of administration same strength |
| gptkbp:reviewedBy |
gptkb:FDA_Center_for_Drug_Evaluation_and_Research
|
| gptkbp:subject |
user fees under GDUFA
|
| gptkbp:triggeredBy |
patent litigation
|
| gptkbp:bfsParent |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:bfsLayer |
5
|