NDA

NDA. A new drug application filed with the FDA under Section 505(b) of the Act (21 U.S.C. 355(b)), as amended and in effect from time to time.

NDA. A "new drug application" as such term is used under the United States Federal Food, Drug and Cosmetic Act and regulations promulgated thereunder.

NDA. Shall mean a New Drug Application and all supplements filed pursuant to the requirements of the FDA, including all documents, data and other information concerning Licensed Product which are necessary for, or included in, FDA approval to market Licensed Product as more fully defined in 21 C.F.R. ss.ss.314.5 et seq. as well as equivalent submissions to the appropriate health authorities in other countries in the Territory, provided further that with respect to the European Union, such... application is to be under the E. U. Centralized Procedure. View More

NDA. Means an application filed with the FDA for approval by the FDA of the sale of the Product in the United States, whether such application is characterized as a New Drug Application or otherwise.

NDA. Shall mean a New Drug Application as defined by the FDA.

NDA. The term "NDA" shall mean either a New Drug Application and/or a Pre-Market Approval for a Licensed Product that has been submitted to the FDA pursuant to the Federal Food, Drug and Cosmetic Act, as amended [Title 21, United States Code] and the regulations promulgated thereunder or an equivalent application to another Regulatory Authority.

NDA. Means a New Drug Application in the U.S., or the analogous process as defined in applicable laws and regulations by which application is made with the appropriate Regulatory Agency of a given country for approval to market a drug in that country.

NDA. Shall mean a New Drug Application under the United States Federal Food, Drug and Cosmetics Act and the regulations promulgated thereunder.

NDA. Shall mean any filing of a New Drug Application made with the Regulatory Authority in the Territory for NDA Approval with respect to the Product.

NDA. Means a New Drug Application, as such term is defined by the FDA, and any equivalent filing in a foreign jurisdiction.