SANDOZ ANDA PRODUCT

SANDOZ ANDA PRODUCT. As used herein, "Sandoz ANDA Product" means the treprostinil injection for subcutaneous or intravenous use pharmaceutical products that are described in, and are the subject of, the Sandoz ANDA (including the active pharmaceutical ingredient ("API") for inclusion in such products but not API for inclusion in any other products) as generic versions of the Remodulin® Drug Products under NDA No. 21-272, as supplemented or amended (except to the extent such supplement or amendment pertains solely... to the Remodulin Implantable System or the DEKA pre-filled semi-disposable pump system). Sandoz ANDA Product shall expressly not include any generic versions of any other UTC drug product(s) or any technology associated with any UTC product(s) or any applications or uses of treprostinil other than the Remodulin® Drug Products. View More