Supernus NDA definition

Supernus NDA means Supernus’ NDA No. 201635, as amended, or supplemented, for the Regulatory Approval of the product sold under the Trokendi XR® trademark or any successor trademark thereto.
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Supernus NDA means NDA No. 201635, as amended, or supplemented.
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Supernus NDA means NDA No. 202810, as amended, or supplemented.
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Examples of Supernus NDA in a sentence

  • Prior to the Zydus 200 mg Product License Date, Supernus will provide written notice to Zydus within ten (10) Business Days after each time either (i) Supernus submits a document to FDA seeking a change in the Label for the Trokendi XR Product, including any specific Labeling amendments or supplements to the Supernus NDA or (ii) FDA communicates to Supernus a suggestion or directive to make a change to the Label for the Trokendi XR Product.


More Definitions of Supernus NDA

Supernus NDA means NDA No. 201635, as amended, or supplemented. EXECUTION COPY
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Related to Supernus NDA

  • Pfizer shall have the meaning set forth in the preamble.

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

  • Elan means Elan Corp and its Affiliates.

  • ONYX means Onyx Acceptance Corporation, and its successors.

  • BMS means the Company, all related companies, affiliates, subsidiaries, parents, successors, assigns and all organizations acquired by the foregoing.

  • Merck has the meaning set forth in the preamble.

  • BLS means Basic Life Support.

  • PTI means Preliminary Toxicity Investigation. Up to a 30-day period where the permittee investigates the cause(s) of a whole effluent toxicity exceedance and if the toxicity is known, includes a proposal for its elimination.

  • NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.

  • PTC means the tax credit for electricity produced from certain renewable generation resources described in Section 45 of the Internal Revenue Code of 1986, as it may be amended or supplemented from time to time.

  • Shire means Shire of Augusta Margaret River

  • Lilly has the meaning set forth in the Preamble.

  • GSK will have the meaning set forth in the Preamble.

  • GTC means General Terms & Conditions of Contract.

  • NPS means nominal pipe size.

  • SPI means the information categories listed at Tex. Bus. & Com. Code § 521.002(a)(2).

  • CTI means CTI Logistics Limited (ABN 69 008 778 925) and/or any Affiliate of CTI Logistics Limited as the case may be, which performs all or any of the Services.

  • ISIS means the department’s individualized services information system.

  • Soil scientist means an individual duly qualified in accordance with standards set by the Federal Office of Personnel Management.

  • DMF means any drug master file filed with the FDA, and any equivalent filing in other countries or regulatory jurisdictions.

  • PMDA means Japan’s Pharmaceuticals and Medical Devices Agency and any successor agency(ies) or authority having substantially the same function.

  • Raptor means all birds of the orders Falconiformes and Strigiformes, commonly called falcons,

  • ANDA means an Abbreviated New Drug Application filed with the FDA pursuant to its rules and regulations.

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • CDC means Centers for Disease Control and Prevention.

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.