NDA

NDA. A new drug application (or any successor form or application having substantially the same effect with respect to the approval of a drug for marketing and sale)

NDA. Shall mean a United States New Drug Application.

NDA. A New Drug Application (as described in 21 C.F.R. § 314) that is submitted to the U.S. Food and Drug Administration ("FDA") to propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S.

NDA. Means a New Drug Application, or the equivalent submission, submitted to the applicable Regulatory Agency.

NDA. A New Drug Application as submitted to the FDA for marketing approval in the United States, or similar marketing license applications in other countries.

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