NDA

NDA. That certain Mutual Non-Disclosure Agreement between the parties dated as of May 8, 2006

NDA. A New Drug Application for a Licensed Product submitted to the FDA or a comparable application submitted to another Regulatory Agency.

NDA. A New Drug Application filed pursuant to the requirements of the FDA.

NDA. A new drug application (Form FDA 356h), or any successor form or foreign equivalent.

NDA. A New Drug Application or a Product License Application, as the case may be, to be filed with the FDA, or the equivalent thereof in other countries or regulatory jurisdictions.

NDA. Means New Drug Application, as described in FDA regulations, 21 C.F.R. 50, including all amendments and supplements to the application.

NDA. A New Drug Application filed with the FDA or any equivalent filed with the regulatory authorities in any country or territory other than the United States to obtain approval for the marketing and sale of a Product in such country or territory, but excluding any pricing or reimbursement approvals.

NDA. A New Drug License approval application, as defined in the Act, and the regulations promulgated thereunder

NDA. A New Drug Application, as defined in the United States Federal Food, Drug and Cosmetic Act, as amended, and all regulations promulgated thereunder

NDA. A New Drug Application or its equivalent (and including any amendments or supplements thereto) that is filed pursuant to the requirements of the FDA, as defined in 21 C.F.R. § 314 et seq., to obtain FDA approval to commercialize a pharmaceutical product in the United States.