NDA

Example Definitions of "NDA"
NDA. A New Drug Application submitted to the FDA seeking approval to market and sell a PRODUCT in the United States of America, or a corresponding application filed with any other regulatory agency seeking approval to market and sell a LICENSED PRODUCT in a country in the TERRITORY.
NDA. Means a New Drug Application, or any successor applications or procedures, filed with the FDA for approval to market and sell a product in the United States.
NDA. A New Drug Application, Marketing Application Authorization or similar application or submission for regulatory approval of a Licensed Product filed with the FDA, or its foreign equivalent thereof, to obtain marketing approval for a pharmaceutical product in the applicable country or group of countries.
NDA. Defined in paragraph 14.c
NDA. A New Drug Application submitted to the FDA for marketing approval of a Product for use in the Field of Use
NDA. Means a New Drug Application.
NDA. Non-Disclosure Agreement which is attached hereto as Addendum B
NDA. A New Drug Application, as defined by the Act and FDA, including but not limited to any such application filed under section 505(b)(2) of the Act
All Definitions