NDA

NDA. A New Drug Application submitted to the FDA in the United States for the PRODUCT.

NDA. A New Drug Application submitted to the FDA

NDA. The new drug application for a Product as required by the FDA, as amended or supplemented from time to time

NDA. A New Drug Application, Biologies License Application, Worldwide Marketing 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 Marketing Authorization of a Licensed 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. A New Drug Application filed with the FDA pursuant to and under 21 U.S.C. § 355(b) of the Act, together with the FDA's implementing rules and regulations

NDA. Means Blake's New Drug Application for the Product, as such application type is defined in the United States Federal Food, Drug and Cosmetic Act, and applicable regulations promulgated thereunder, as amended from time to time.

NDA. A New Drug Application filed with the FDA in accordance with Applicable Law

NDA. Means a New Drug Application, Abbreviated New Drug Application, Biologics License Application, or similar application which is required to be filed with the FDA to obtain a marketing approval of a Product in the United States

NDA. Means a New Drug Application as described in 21 C.F.R. Part 314, filed with the FDA after completion of clinical trials to obtain Approval for a Licensed Product in the United States.

NDA. Defined in the Commercial License Agreement