NDA
NDA. A New Drug Application, Product License Application or the equivalent, which is filed with the United States Food and Drug Administration (or any successor agency) seeking approval to market and sell a Product in the Field in the United States, as well as any corresponding applications or approvals for the Product in the Field in Canada.
Found in
VIROPHARMA INC contract
NDA. Means ViroPharma's New Drug Application Number 50-606 for the Product, as such application type is defined in the United States Federal Food, Drug and Cosmetic Act, and applicable regulations promulgated thereunder, as amended from time to time.
Found in
VIROPHARMA INC contract
NDA. Means that certain Mutual Non-Disclosure Agreement between the parties dated as of November 30, 2006.
Found in
CAMBRIDGE HEART INC contract
NDA. Means that certain non-disclosure agreement between CHI and Distributor dated as of September 5, 2008.
Found in
CAMBRIDGE HEART INC contract
NDA. Means a new drug application filed with the FDA to obtain marketing approval for Product in the United States.
Found in
CUBIST PHARMACEUTICALS INC contract
NDA. Means a New Drug Application under the Act in the United States.
NDA. Means a new drug application or supplemental new drug application or any amendments thereto submitted to the FDA for marketing authorization of the Product in the United States, or any equivalent application in Japan.
Found in
Durata Therapeutics, Inc. contract
NDA. The new drug application related to each Product, submitted to the FDA pursuant to provisions of the Act and applicable regulations related thereto.
Found in
SANTARUS INC contract
NDA. The "NDA"
Found in
AMBIENT CORP contract
NDA. Means a New Drug Application, as defined in the United States Federal Food, Drug, and Cosmetic Act, as amended and regulations promulgated thereunder, or any successor application or procedure to market a Product or Non-Exclusive Product.
All Definitions
Found in
Fusion Pharmaceuticals Inc. contract