Statements (22)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
submission
|
| gptkbp:alsoKnownAs |
gptkb:Abbreviated_New_Drug_Application
|
| gptkbp:appliesTo |
generic drug products
|
| gptkbp:compatibleWith |
preclinical studies
clinical studies (except in certain cases) |
| gptkbp:contrastsWith |
gptkb:505(b)(2)_application
505(b)(1) application |
| gptkbp:enables |
market entry of generic drugs
generic competition |
| https://www.w3.org/2000/01/rdf-schema#label |
505(j) application
|
| gptkbp:includes |
labeling information
patent certification bioequivalence data chemistry, manufacturing, and controls information |
| gptkbp:legalBasis |
Section 505(j) of the Federal Food, Drug, and Cosmetic Act
|
| gptkbp:purpose |
approval of generic drugs
|
| gptkbp:regulates |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:requires |
reference listed drug
demonstration of bioequivalence |
| gptkbp:YouTubeChannel |
gptkb:ANDA
|
| gptkbp:bfsParent |
gptkb:21_U.S.C._§_355
|
| gptkbp:bfsLayer |
8
|