NDA

NDA. A New Drug Application, designated #20-87 and dated March 14, 1996.

NDA. Means that certain Non-Disclosure Agreement by and between WESTERN DIGITAL and SHOWA DENKO dated as of April 8, 2003.

NDA. Means a New Drug Application filed with the FDA pursuant to its rules and regulations.

NDA. Means a new drug application or similar application for marketing approval of a pharmaceutical product submitted to the PMDA.

NDA. 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 (or, in a country other than the United States, the equivalent necessary submissions to the applicable regulatory authority for Marketing Approval).

NDA. Means an application (whether original, supplementary or abbreviated) to the applicable Regulatory Authority in a country of the Territory, for approval by such Regulatory Authority, necessary for the commercial sale of Product in CONFIDENTIAL TREATMENT REQUESTED *** TEXT OMITTED AND FILED SEPARATELY CONFIDENTIAL TREATMENT REQUESTED ... UNDER 17 C.F.R. SECTIONS 200.80(b)(4) AND 230.406 such country. An NDA, together with all supplemental filings referencing the initial NDA filing, shall be deemed one and the same NDA for all purposes of this Agreement. View More

NDA. Means the New Drug Application relating to Valrubicin approved by the FDA on September 25, 1998.

NDA. Shall mean any New Drug Application under the Act (together with all subsequent submissions, supplements and amendments thereto, and any materials, documents or information referred to or relied upon thereby) seeking approval to market, sell or otherwise distribute the Product, in any formulation or dosage form, in the United States, and similar applications or filings in the countries within the Territory.

NDA. Shall mean a New Drug Application under the Act, a Product License Application or a corresponding filing required in any country of the Territory seeking approval to market the Finished Dosage Form.

NDA. Means a New Drug Application under 21 C.F.R. Part 314, or such other form of application or filing as may be required as a legal prerequisite to the commencement of commercial sale and human use of a Covered Product in the United States.