Example Definitions of "aNDA"
aNDA. An Abbreviated New Drug Application for the Product submitted to the FDA, including any amendments or supplements thereto
aNDA. Means any abbreviated new drug application required to manufacture, market and sell finished dosage forms of the Drag Product (as defined below) in the United States and its territories and possessions filed by or on behalf of Aradigm's Designated Manufacturer with the FDA pursuant to 21 U.S.C. 355(j), and any amendments thereto which may be filed by Aradigm's or its Designated Manufacturer from time to time, and any foreign equivalent of such application.
aNDA. An Abbreviated New Drug Application filed with the FDA (as more fully defined in 21 USC ยง355(j)
aNDA. Shall mean any Abbreviated New Drug Application covering the Product and filed with the FDA pursuant to the U.S. Federal Food, Drug, and Cosmetic Act, as amended, or any regulations thereunder.
aNDA. The Abbreviated New Drug Application #75-117 and/or submissions, amendments, modifications, supplements and updates thereto, approved by the FDA related to the marketing and sale of the Branded Product and the Product
aNDA. Abbreviated New Drug Applications for Orapred and Orapred RT listed in Exhibit A
aNDA. Abbreviated new drug application
aNDA. An abbreviated new drug application or similar health registration application that is or will be filed with a Regulatory Authority to obtain Regulatory Approval to market a Product in the Territory.
aNDA. Means an Abbreviated New Drug Application.
All Definitions