NDA definition

NDA means a New Drug Application filed with the FDA after completion of Clinical Studies to obtain Approval for a Product in the United States.
NDA means a New Drug Application, or similar application for marketing approval of a Product for use in the Field submitted to the FDA, or its foreign equivalent.

Examples of NDA in a sentence

  • The NDA submission lacks data needed to establish that the change in negative symptoms of schizophrenia with roluperidone treatment was clinically meaningful.

  • The NDA submission lacks data on concomitant antipsychotic administration.

  • Pursuant to the terms of the license, Supemus also granted to Apotex a selective and limited waiver of any unexpired periods of pediatric and/or other statutory or regulatory exclusivities that might be listed in the Orange Book in connection with NDA No. 202810 with respect to the above-referenced ANDA No. 213369 held by Apotex Inc.

  • Supernus hereby selectively waives its right to any unexpired periods of pediatric and/or other statutory or regulatory exclusivities listed in connection with NDA No. 202810, solely to the extent necessary to enable the approval of ANDA No. 213369 for oxcarbazepine extended release tablets.


More Definitions of NDA

NDA means a New Drug Application (as more fully defined in 21 C.F.R. 314.5 et seq. or its successor regulation) and all amendments and supplements thereto filed with the FDA.
NDA means a New Drug Application filed with the FDA as described in 21 C.F.R. § 314, a Biological License Application (BLA) pursuant to 21 C.F.R. § 601.2, or any equivalent or any corresponding application for regulatory approval in any country or regulatory jurisdiction other than the United States.
NDA means a New Drug Application, Biologics License Application, Marketing Authorization Application, filing pursuant to Section 510(k) of the United States Federal Food, Drug and Cosmetic Act, or similar application or submission for a marketing authorization of a product filed with a Regulatory Authority to obtain marketing approval for a biological, pharmaceutical or diagnostic product in that country or in that group of countries.
NDA means the new drug application for a product, including the Product, requesting permission to place a drug on the market in accordance with 21 C.F.R. Part 314, and all supplements filed pursuant to the requirements of the FDA, including all documents, data, and other information filed concerning such product that are necessary for FDA approval to market such product in the Territory.
NDA means a new drug application filed or to be filed with the FDA as described in 21 CFR Part 314, or the equivalent filing with a relevant Regulatory Authority in any jurisdiction (including a marketing authorization application filed or to be filed with the EMA or Health Canada), together with any amendments, supplements or other additions or deletions thereto.
NDA means a New Drug Application submitted to the FDA seeking approval to market and sell a Drug Product in the Field in the United States of America, or a corresponding application filed with any other regulatory agency seeking approval to market and sell a Drug Product in the Field in another Major Market Country.