FOLIO Ontology

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Identification

IRI:
https://folio.openlegalstandard.org/RCsgBzhoO77TRUSo5O757qS
Label Abbreviated New Drug Application Claim
Preferred Label ANDA Claim
Identifier N/A
Alternative Labels
ANDA Dispute Claim Bioequivalence Application Claim Generic Drug Application Claim Generic Medicine Application Claim

Definition

An Abbreviated New Drug Application (ANDA) Claim arises when there is a dispute or legal challenge related to the submission or approval of an ANDA, which allows for the marketing of a generic drug that demonstrates bioequivalence to an already approved brand-name drug. This claim can involve issues of patent infringement, exclusivity rights, or regulatory compliance.

Class Relationships

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Additional Information

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Comment

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Description

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Notes

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Editorial Information

History Note

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Editorial Note

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Deprecated

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Source and Origin

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