Product NDA definition

Product NDA means any NDA filed in the Territory which seeks Regulatory Approval for a Product in the Field, including any supplements or amendments thereto.
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Product NDA means the New Drug Application filed with the FDA for the Product pursuant to the Federal Food, Drug and Cosmetic Act and the regulations promulgated thereunder, and any amendments or Supplemental New Drug Applications thereto, or documents incorporated by reference.
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Product NDA means NDA No. 21-748 filed with FDA on April 27, 2004, including, without limitation, any and all amendments and supplements thereto and all written FDA communications related thereto, whether existing on the NDA Transfer Date or filed thereafter.
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Examples of Product NDA in a sentence

  • On the NDA Transfer Date, Titan shall submit to the FDA a letter authorizing the transfer of ownership from Titan to Braeburn of the Product NDA.

  • To Depomed’s knowledge, the Product NDA and other regulatory filings submitted to the FDA in support of marketing approval for the Products do not contain any material misstatement of a material fact related to safety or efficacy nor omit to state any material fact in Depomed’s possession related to safety or efficacy of the Products.

  • As the sponsor of the Product NDA, Purinix shall ensure that the results of its study are supported by source documentation, shall include reports on serious adverse events (SAE), and, where required, filings to the FDA at a pre-IND meeting, pre-NDA meeting, and/or in the NDA submission with respect to the Product shall include relevant Patient Records data.

  • Depomed has not received any written communication from FDA stating that any Post-Marketing Development activities are required by the FDA as a condition to maintenance of the Product NDA.

  • Parity with Non-Resident Indian to appear for the All India Pre-medical Test or such other tests to make them eligible for admission in pursuance of the provisions contained in the relevant Acts.


More Definitions of Product NDA

Product NDA means the NDA owned by Titan as of the Effective Date relating to Probuphine® (No. 204442), together with all amendments, supplements and updates thereto, as well as the corresponding IND (IND 70852).
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Product NDA means the New Drug Application (“NDA”) to be filed with the FDA seeking approval of the Product (or any subsequent NDA filed with the FDA for any other strength, dosage or indication for the Product not included in the first NDA for the Product) for marketing, sale and use in the Field in the United States. THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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Product NDA means [***], including all amendments, supplements, variations, extensions and renewals thereof.
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Product NDA means the New Drug Application filed by Seller seeking marketing approval for the Products.
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Product NDA means the NDA (NDA File No. 21-514) submitted to the FDA by Manufacturer on June 27, 2002, seeking approval to market the Product for the treatment of ADHD, along with any amendments, correspondence or supplements thereto and incorporated therein.
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Product NDA the New Drug Applications (as defined in and regulated under the FDA Act) identified as [***] and [***] including all applications therefor, and all amendments, modifications, supplements, submissions, and updates with respect thereto.
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Product NDA means the NDA obtained by TRIS related to a Product.
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