ANDA Product definition

ANDA Product means each of the following products (including any future packaging changes or pack sizes): (a) the XXXXX Products; (b) the XXXXX Products; (c) the XXXXX Products; and (d) the XXXXX Products.
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ANDA Product means the product to be manufactured under the ANDA that is the subject of the Patent Infringement Claim.
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ANDA Product means a Generic OMIDRIA Product sold, offered for sale or distributed pursuant to ANDA No. 210183, including supplements or amendments to ANDA No. 210183, but excluding any such supplements or amendments after the original filing date of ANDA No. 210183 that change the mode of administration or active ingredient(s).
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Examples of ANDA Product in a sentence

  • On information and belief, the administration of the Natco ANDA Product will occur with Natco’s specific intent and encouragement, and will be conduct that Natco knows or should know will occur.

  • Israel & the EU - Institutional Framework.Retrieved from http://eeas.europa.eu/delegations/israel/eu_israel/political_relations/institutio nal_framework/index_en.htmEuropean Forum for Democracy and Solidarity.

  • If Natco’s marketing and sale of the Natco ANDA Product prior to expiration of the ’342 patent and all other relevant exclusivities are not enjoined, Gilead will suffer substantial and irreparable harm for which there is no remedy at law.

  • Navinta's manufacture and sale of a 0.2% ANDA Product will infringe claims 1, 2, 3, and 6 of the ‘086 Patent for all the reasons set forth above with respect to Navinta's 0.5% and 1.0% ANDA Products.

  • Before Navinta submitted this amendment, Sandoz's Dave Picard generated marketing forecasts of projected sales for a 0.2% ANDA Product.


More Definitions of ANDA Product

ANDA Product means the products to be supplied by HMRI to Rugby pursuant to the Contract Manufacturing Agreement.
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ANDA Product means a generic drug active pharmaceutical ingredient in finished dosage form, (injectable, lyophilized, powder fill, soft gel capsule or tablet), approved by the FDA for sale in the United States pursuant to an ANDA, but excluding specifically Patent Challenging Products.
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ANDA Product means a Drug Product manufactured under an ANDA.
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ANDA Product means each Product designated as an ANDA Product on Section 4(u)(vii) of the Disclosure Schedule.
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ANDA Product means a product that is the subject of an Abbreviated New Drug Application, as defined under 21 U.S.C. § 355(j), filed by a Third Party with the FDA, for which the Licensed Product is the reference listed drug.
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ANDA Product means a Product for which Regulatory Approval has been granted on the basis of an ANDA.
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ANDA Product means a pharmaceutical product that (a)(i) is a bendamustine hydrochloride solution, and (ii) is therapeutically equivalent to the Bendeka® NDA Product, as manufactured or sold for use in the Territory in a 100 mg/4 mL (25 mg/mL) dosage strength in a multiple-dose vial, and (iii) has an FDA approved label [***] and (b) is sold, offered for sale or distributed under an ANDA that references the Bendeka® NDA Product as the reference-listed drug, and is filed or otherwise controlled by a person or entity other than Plaintiffs or their Affiliates. For the avoidance of doubt, the Dr. Reddy’s Product is not an ANDA Product, and ANDA Product does not include (1) [***], or (2) [***].
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