Drugs

ANDA (Generic) Drug Approvals - Previous Years

A tentative approval is issued to the applicant when the application is approvable prior to the expiration of any patents or exclusivities accorded to the reference listed drug product. A tentative approval does not allow the applicant to market the generic drug product and postpones the final approval until all patent/exclusivity issues have expired. First Generics are those drug products that have never been approved before as generic drug products and are new generic products to the marketplace.

Page Last Updated: 01/20/2015
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