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.