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. {***} Confidential portions of this exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance with Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
ANDAs means collectively or either, as the case may be, the 21-Day ANDA and the 28-Day ANDA.
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.
More Definitions of ANDAs
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 Abbreviated New Drug Applications filed by Borrower with the United States Food and Drug Administration.
ANDAs means Abbreviated New Drug Applications made to the FDA.
ANDAs means, in respect of any Product, the new drug application or abbreviated new drug application, as the case may be, filed with the FDA by Genpharm or its Affiliate with respect to such Product;
ANDAs means the Abbreviated New Drug Applications numbered [REDACTED] and [REDACTED] 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 in the name of the Vendor or NutraMax used in the Business;