Statements (24)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
FDA guidance document
|
| gptkbp:availableOn |
FDA website
|
| gptkbp:focusesOn |
gptkb:Abbreviated_New_Drug_Application
|
| gptkbp:guidanceSystem |
administrative information for ANDA
electronic submission of ANDA filing requirements for ANDA format and content of ANDA preparing ANDA submissions technical requirements for ANDA |
| https://www.w3.org/2000/01/rdf-schema#label |
ANDA Submissions guidance
|
| gptkbp:issuedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:relatedTo |
labeling requirements
user fees drug master files bioequivalence studies generic drug approval 180-day exclusivity ANDA amendments and supplements FDA review process patent certifications |
| gptkbp:targetAudience |
pharmaceutical industry
generic drug applicants |
| gptkbp:bfsParent |
gptkb:FDA_guidance
|
| gptkbp:bfsLayer |
7
|