aNDA

Example Definitions of "aNDA"
aNDA. An Abbreviated New Drug Application for the Product submitted to the FDA, including any amendments or supplements thereto
Found in Sagent Pharmaceuticals, Inc. contract
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.
Found in ZOGENIX, INC. contract
aNDA. An Abbreviated New Drug Application filed with the FDA (as more fully defined in 21 USC ยง355(j)
Found in Cardiovascular Systems Inc contract
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.
Found in CUMBERLAND PHARMACEUTICALS INC contract
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
Found in BIOMARIN PHARMACEUTICAL INC contract
aNDA. Abbreviated New Drug Applications for Orapred and Orapred RT listed in Exhibit A
Found in BIOMARIN PHARMACEUTICAL INC contract
aNDA. Abbreviated new drug application
Found in Spectrum Pharmaceuticals, Inc. contract
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.
Found in ANI Pharma Inc contract
aNDA. Means an Abbreviated New Drug Application.
Found in CATALYST BIOSCIENCES, INC. contract
All Definitions