Product ANDA definition

Product ANDA means, for each applicable Product, respectively, the Abbreviated New Drug Application (as defined in the United States Food, Drug, and Cosmetic Act) identified on Exhibit C, and all amendments and supplements thereto, that have been filed with the FDA seeking authorization and approval to manufacture, package, ship and sell such Products, as more fully defined in 21 C.F.R. Part 314 et seq.
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Product ANDA means the ANDA owned by Insys which has been issued by the FDA specifically for marketing the Product in the Territory.
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Product ANDA means an ANDA filed by Par for the Product pursuant to this Agreement to seek marketing approval by the FDA wherein the same may be supplemented and/or amended as required.
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Examples of Product ANDA in a sentence

  • Notwithstanding the foregoing, nothing herein shall constitute a guarantee or warranty from Seller that the ANDA for the Product will be approved by the FDA, or, if the Product ANDA is approved, any market exclusivity will be awarded, or any other regulatory approvals will be obtained by Seller or that a Favorable Resolution will be obtained.

  • As of the date hereof, Buyer has not begun developing a generic version of any Product, has not filed a Product ANDA for a generic version of any Product, and does not own or have a right to distribute any product under a Product ANDA for a generic version of any Product or the corresponding NDA.

  • Subject to the terms and conditions of this Agreement, Noven hereby grants to Endo an exclusive license under the Product ANDA and its Intellectual Property Rights solely to use and sell or otherwise dispose of the Licensed Product solely in the Territory.

  • Noven will be responsible for obtaining, and will use commercially reasonable efforts to obtain, Regulatory Approval of the Product ANDA in the United States.

  • Noven agrees to keep Endo fully informed of its progress in seeking Regulatory Approval, including providing Endo with copies of any and all correspondence between Noven and the FDA relating to the Product ANDA.


More Definitions of Product ANDA

Product ANDA means ANDA no. 76-804, filed by Noven pertaining to a fentanyl transdermal patch product.
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Product ANDA means ANDA #A202939, as the same may be supplemented or amended from time to time.
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Product ANDA means the Abbreviated New Drug Application approval issued to Eon by the FDA and designated as ANDA #75-434 (as defined below) for the Product, including any amendments or modifications thereto.
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Product ANDA means, for each applicable Product, respectively, the Abbreviated New Drug Application (as defined in the United States Food, Drug, and Cosmetic Act) identified on Exhibit C, and all amendments and supplements thereto, that have been filed with the FDA seeking authorization and approval to manufacture, package, ship and sell such Products, as more fully defined in 21 C.F.R. Part 314 et seq. [****] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Confidential treatment has been requested with respect to the omitted portions.
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Product ANDA means an Abbreviated New Drug Application (ANDA) for the Development Products and the Commercial Products filed with the FDA by Purepac or one of its Affiliates.
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Product ANDA means the ANDA No. [____] for formulations of [_____________________] for oral administration.
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Product ANDA means the ANDA set forth on Schedule 1 hereto, as filed with the FDA as a generic equivalent to the corresponding RLD, and all amendments, supplements or annual reports thereto.
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