Neos NDA definition

Neos NDA means NDA 204326, and any amendment or supplement thereto.
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Neos NDA means New Drug Application No. 205489. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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Neos NDA means New Drug Application No. 204326.
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Examples of Neos NDA in a sentence

  • Subject to Actavis’s compliance, neither shall Neos nor any of its Affiliates Officially Discontinue the products described in the Neos NDA prior to the expiration of the Licensed Patents, unless required, requested, or recommended to do so by the FDA or other governmental authority or applicable law.

  • Subject to Teva’s compliance, neither shall Neos nor any of its Affiliates Officially Discontinue the products described in the Neos NDA prior to the expiration of the Licensed Patents, unless required, requested, or recommended to do so by the FDA or other governmental authority or applicable law.

  • Notwithstanding the above, Neos shall be permitted to disclose to the FDA the existence of this Agreement and the fact that the Licensed Patents are licensed for purposes of obtaining Regulatory Approval of the Neos NDA.

Related to Neos NDA

  • NDA means a New Drug Application, as defined in the United States Federal Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or similar application filed with an equivalent regulatory body in another country.

  • ANDA means an Abbreviated New Drug Application, or similar application for marketing approval of a Product submitted to the FDA.

  • ONYX means Onyx Acceptance Corporation, and its successors.

  • Pfizer means Pfizer Inc.

  • Novartis shall have the meaning set forth in the Preamble.