Teva ANDA definition

Teva ANDA means Teva’s ANDA No. 209431 for oxycodone extended-release capsules, 9 mg, 13.5 mg, 18 mg, 27 mg, and 36 mg, including any amendments, supplements or replacements thereto.
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Teva ANDA means, as applicable, ANDA Number 75-435 for the Capsule Product and ANDA No. 75-827 for the Tablet Product.
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Teva ANDA means ANDA No. 213195 for a Generic Extended Release Naltrexone Product.
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Examples of Teva ANDA in a sentence

  • In addition, such Party shall give notice to the other Parties of its intent to disclose as soon as practical, and in addition provide the text of such disclosure to the other Parties at least 24 hours in advance prior to its release to the public.

  • No provision of this Settlement Agreement shall be affected by any delay in the approval of either of the Teva ANDA by the FDA, or the failure of Teva to obtain FDA approval of the Teva ANDA.

  • For the further avoidance of doubt, the right and license granted under this Section 2.1 shall not apply to the Manufacture or distribution of any finished product aside from the Teva ANDA Products, or to the supply of API or any other ingredients for any finished product aside from the Teva ANDA Products.

  • Defendants acknowledge, on behalf of themselves and their Affiliates, that, notwithstanding the definition of the ANDA License Start Date, Defendants might not be able to legally exploit the ANDA License with respect to the Teva ANDA Product for various reasons, including exclusivity granted by the FDA to Third Parties, lack of regulatory approval for the Teva ANDA by the FDA or blocking intellectual property rights owned or controlled by a Third Party.

  • The two Bayer Healthcare patents were also the subject of another Teva ANDA seeking approval to sell a generic version of Bayer Healthcare's systematic moxifloxacin product, Avelox®.

  • Plaintiff has prosecuted, and Defendants have defended, an action for patent infringement in the United States District Court for the District of Delaware (the “District Court”) regarding the Teva ANDA and the proposed generic product that is the subject thereof, which action is captioned Cubist Pharmaceuticals, Inc.

  • For the avoidance of doubt, the right and license granted under this Section 2.1 shall not apply to the Manufacture or distribution of Teva ANDA Products for sale to Third Parties for use or consumption outside the Territory.

  • Notwithstanding the foregoing, nothing herein shall prevent Teva from maintaining a “Paragraph IV Certification” under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (as amended or replaced) within the Teva ANDA with respect to the Licensed Patents that may be listed in the Orange Book for the NDA Products.

  • Teva acknowledges, agrees and admits that, in connection with the Teva Product and the Teva ANDA only, the Licensed Patent is valid and enforceable and that the manufacture, use, sale, offer for sale, or importation of Teva Product in or for the Territory infringes one or more claims of the Licensed Patent.

  • Nothing in this Agreement shall be interpreted as Plaintiff’s consenting to approval from the FDA or any other applicable regulatory authority for Defendants to manufacture, use, sell or offer to sell the Teva ANDA Product in the Territory, or to import the Teva ANDA Product into the Territory, except as expressly provided herein.


More Definitions of Teva ANDA

Teva ANDA means Teva’s ANDA No. 210924 as supplemented and amended as of the Execution Date of this License Agreement and including any Permitted Modification after the Execution Date of this License Agreement.
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Teva ANDA shall have the meaning assigned to such term in the Recitals.
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Related to Teva ANDA

  • MFDA means the Mutual Fund Dealers Association of Canada;

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

  • Distillery manufacturing license means a license issued in accordance with

  • Bioassay means the determination of kinds, quantities or concentrations and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these rules, “radiobioassay” is an equivalent term.

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products

  • Shire means Shire of Augusta Margaret River

  • Milk product or "dairy product" means cottage cheese, dry curd cottage cheese, reduced fat cottage cheese, lowfat cottage cheese, cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, flavored milk, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk, milk products with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Unless a product is considered a milk product under this subdivision, milk product does not include dietary products, infant formula, ice cream or other desserts, cheese, or butter. Milk products include the following:

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

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.

  • Generic Version means, with respect to a Licensed Product, a product (including a “biogeneric,” “follow-on biologic,” “follow-on biological medicine or product,” “follow-on protein product,” “similar biological medicine or product,” or “biosimilar product”) that: (a) within the U.S., is “biosimilar” or “interchangeable,” with respect to such Licensed Product as evaluated by the FDA or otherwise determined by Applicable Law; or (b) in the ROW, is determined by the applicable Regulatory Authority or by Applicable Law to be “similar,” “comparable,” “interchangeable,” “bioequivalent,” or “biosimilar” to such Licensed Product. For clarity, a Biosimilar of a Licensed Product shall constitute a Generic Version of such Licensed Product.

  • NPS means nominal pipe size.

  • PMA means the annual product multiplier and/or seasonal factor as appropriate for Gas Year t, in accordance with the “Gas Product Multipliers and Time Factors Table”.

  • Spectrum means frequencies of electromagnetic spectrum used to provide fixed or mobile communications services as licensed or authorized by the FCC.

  • Marijuana products means concentrated marijuana products and marijuana products that are comprised of marijuana and other ingredients and are intended for use or consumption, such as, but not limited to, edible products, ointments, and tinctures.

  • Sub-Licensee means all person/ agency with whom Licensee has executed sub license agreement as per terms and conditions of license agreement executed between DMRC and the Licensee, for commercial utilization of the Bare Spaces.

  • IPPF means the indigenous peoples planning framework for the Investment Program, including any update thereto, agreed between the Borrower and ADB and incorporated by reference in the FFA;

  • in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

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

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • LGA means LaGuardia Airport, New York.

  • mg means milligram.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Drug store means a place whose principal business is, the

  • We/Our/Us means the Underwriters named in the Schedule.

  • API means American Petroleum Institute.

  • 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.