NDA Definition: 7k Samples

NDA means a New Drug Application, or similar application for marketing approval of a Product for use in the Field submitted to the FDA, or its foreign equivalent.

Examples of NDA in a sentence

In addition, the other Party may request the conclusion of an NDA with the third party.
This Agreement, together with all schedules, exhibits and any other documents incorporated herein by reference, and the NDA dated October 18, 2023, constitute the sole agreements of the Parties with respect to the subject matter contained herein, and supersede all prior and contemporaneous understandings and agreements, both written and oral, with respect to such subject matter.
The NDA must have at least the same content and scope as the NDA entered into by the Parties on October 18, 2023.
Pursuant to the terms of the license, Supemus also granted to Apotex a selective and limited waiver of any unexpired periods of pediatric and/or other statutory or regulatory exclusivities that might be listed in the Orange Book in connection with NDA No. 202810 with respect to the above-referenced ANDA No. 213369 held by Apotex Inc.
Supernus hereby selectively waives its right to any unexpired periods of pediatric and/or other statutory or regulatory exclusivities listed in connection with NDA No. 202810, solely to the extent necessary to enable the approval of ANDA No. 213369 for oxcarbazepine extended release tablets.

NDA means a New Drug Application (as more fully defined in 21 C.F.R. 314.5 et seq. or its successor regulation) and all amendments and supplements thereto filed with the FDA.

NDA means a New Drug Application, Biologics License Application, Marketing Authorization Application, filing pursuant to Section 510(k) of the United States Federal Food, Drug and Cosmetic Act, or similar application or submission for a marketing authorization of a product filed with a Regulatory Authority to obtain marketing approval for a biological, pharmaceutical or diagnostic product in that country or in that group of countries.

NDA means a New Drug Application, as defined in the FD&C Act, and applicable regulations promulgated thereunder by the FDA, or the equivalent application to the equivalent agency in any other regulatory jurisdiction in the Territory, to obtain approval or authorization to commence marketing and sales of a pharmaceutical product.

NDA means a New Drug Application filed with the FDA as described in 21 C.F.R. § 314, a Biological License Application (BLA) pursuant to 21 C.F.R. § 601.2, or any equivalent or any corresponding application for regulatory approval in any country or regulatory jurisdiction other than the United States.

NDA means a New Drug Application submitted and filed with the FDA or the equivalent application or filing filed with any equivalent agency or government authority outside of the United States (including any supra-national agency such as in the European Union) necessary for approval of a drug in such jurisdiction.