N DA definition

N DA means a New Drug Application as defined in the FDCA and regulations promulgated thereunder or any successor application or procedure required to sell a Product in the United States.
N DA means a new drug application in any of the countries in the Territory similar to the NDA submitted to the United States Regulatory Authority to obtain approval for the marketing of a Licensed Product in the United States, together with all subsequent submissions, supplements and amendments thereto.
N DA means a new drug application (as defined in Title 21 of the United States Code of Federal

Examples of N DA in a sentence

  • This Agreement including its annexes contains the entire agreement between the Parties with respect to the subject matter hereunder and supersedes any previous understanding, commitments, and agreements either oral or written, between the Parties, except the N DA dated [●], which remains in full force and effect.