ANDA
E642121
ANDA stands for Abbreviated New Drug Application, the U.S. FDA regulatory pathway that allows approval of generic drugs by demonstrating bioequivalence to an already approved brand-name product.
Statements (47)
| Predicate | Object |
|---|---|
| instanceOf |
Abbreviated New Drug Application
ⓘ
U.S. drug approval application type ⓘ regulatory pathway ⓘ |
| abbreviationFor | Abbreviated New Drug Application NERFINISHED ⓘ |
| applicationType | abbreviated application ⓘ |
| appliesTo | generic drugs ⓘ |
| associatedWith | Orange Book NERFINISHED ⓘ |
| comparedTo | New Drug Application ⓘ |
| differsFrom | New Drug Application ⓘ |
| doesNotRequire |
independent clinical efficacy trials in most cases
ⓘ
independent clinical safety trials in most cases ⓘ |
| fullForm | Abbreviated New Drug Application NERFINISHED ⓘ |
| goal |
ensure therapeutic equivalence to reference listed drugs
ⓘ
provide lower-cost alternatives to brand-name drugs ⓘ |
| includes |
bioequivalence study reports
ⓘ
drug product information ⓘ drug substance information ⓘ manufacturing site information ⓘ proposed labeling ⓘ stability data ⓘ |
| jurisdiction |
United States of America
ⓘ
surface form:
United States
|
| language | English ⓘ |
| legalBasis |
Federal Food, Drug, and Cosmetic Act
NERFINISHED
ⓘ
Hatch-Waxman Amendments NERFINISHED ⓘ |
| mayInclude | biowaiver requests for certain dosage forms ⓘ |
| NDAComparison | relies on existing safety and efficacy data of reference drug ⓘ |
| outcome | approval to market a generic drug in the U.S. ⓘ |
| purpose | approval of generic drug products ⓘ |
| referenceProductType |
brand-name drug
ⓘ
reference listed drug ⓘ |
| regulatedBy |
FDA
NERFINISHED
ⓘ
U.S. Food and Drug Administration NERFINISHED ⓘ |
| relatedTo |
drug patent and exclusivity framework
ⓘ
generic drug competition ⓘ |
| requires |
chemistry, manufacturing, and controls information
ⓘ
demonstration that inactive ingredients are safe ⓘ drug product quality data ⓘ labeling information ⓘ patent certification ⓘ pharmacokinetic bioequivalence studies in many cases ⓘ |
| requiresDemonstrationOf | bioequivalence ⓘ |
| reviewedBy |
FDA Office of Generic Drugs
NERFINISHED
ⓘ
OGD ⓘ |
| submissionFormat |
eCTD
ⓘ
electronic Common Technical Document ⓘ |
| submissionTo |
CDER
NERFINISHED
ⓘ
Center for Drug Evaluation and Research NERFINISHED ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.