ANDAs definition
ANDAs means Abbreviated New Drug Applications listed in Schedule 1 and all amendments thereto, that have to date been filed with the FDA seeking authorization and approval to manufacture, package, ship and sell, as more fully defined in 21 C.F.R. Part 314, the Products.
ANDAs means the Abbreviated New Drug Applications pursuant to 21 U.S.C. §355(j) and regulations promulgated thereunder, and all amendments and supplements thereof as set forth on Schedule 1.3. Buyer hereby acknowledges and agrees that certain of the ANDAs have been filed with the FDA but have not received FDA approval, as indicated on Schedule 1.3.
ANDAs means collectively or either, as the case may be, the 21-Day ANDA and the 28-Day ANDA.
More Definitions of ANDAs
ANDAs means Abbreviated New Drug Applications filed by Borrower with the United States Food and Drug Administration.
ANDAs shall have the meaning set forth in Section 4.06(b).
ANDAs means all the right, title and interest in, to and under the Abbreviated New Drug Applications filed with the FDA pursuant to its rules and regulations and included on Exhibit A.
ANDAs means the Abbreviated New Drug Applications numbered 63-066 and 63-067 which were submitted to the FDA in order to obtain approval to market the Products in the United States, together with all amendments, modifications, supplements and updates thereto.
ANDAs means the Abbreviated New Drug Applications filed with the FDA in connection with the Products.
ANDAs shall include the Amendment No. 2 ANDAs from and after the date hereof.
ANDAs has the meaning set forth in Section 4.11(m).