Product NDAs definition

Product NDAs means (i) Application Number 212379, as filed with the FDA and approved on October 18, 2019 (the “Amzeeq® NDA”) and (ii) Application Number 213690, as filed with the FDA and approved on May 28, 2020 (the “Zilxi® NDA”), in each case, including all amendments, supplements, variations, extensions and renewals thereof through the Closing Date.
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Product NDAs means the NDAs set forth on Annex 1.1(f).
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Product NDAs means the NDAs for Product as set forth on Annex 3.
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Examples of Product NDAs in a sentence

  • Draft Guidance for Industry: Topical Dermatological Drug Product NDAs and ANDAs --- In Vivo Bioavailability, Bioequivalence, In Vitro Release, and Associated Studies.

  • As a result, impacts from mobile sources during operations have been determined to be less than significant.

  • Draft guidance: Topical Dermatological Drug Product NDAs and ANDAs - In Vivo Bioavailability, Bioequivalence, In VitroRelease, and Associated Studies.

  • Avetta helps optimise the on-field performance with respect to security and risk assessment for both the organizations as well as the contractors with real-time feedback and insights.

  • Depomed shall have the right to request review and approve, with reasonable notice, any and all Regulatory Communications, Regulatory Approvals, and related regulatory documents that pertain to the Product NDAs before they are submitted to FDA or other Regulatory Authorities by Collegium or Newco.

  • Each Party shall prepare and provide to the other Party on a timely basis safety updates in order for such other Party to meet the safety report submission requirements necessary to maintain the Product INDs and the Product NDAs held by it.

  • The transfer of the Product NDAs shall be effective on theNDA Transfer Date.

  • Each Party shall assist the other Party, as is reasonably necessary, in order for such Party to obtain and maintain the Product INDs and the Product NDAs, including in connection with the preparation and filing of Regulatory Materials necessary to maintain such Product INDs and Product NDAs. 5.4 Regulatory Costs and Expenses.


More Definitions of Product NDAs

Product NDAs means, collectively, (a) NDA #20-838, (b) NDA #21-093, (c) NDA #020541, (d) NDA #022214, (e) NDA #020498 and (f) NDA #022310.
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Product NDAs means the NDAs filed with the FDA with respect to Products set forth on Schedule 1.160, including all supplements and amendments thereto.
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Product NDAs and “Product ANDAs” mean the NDAs and ANDAs identified in Schedule 1.1(b).
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Product NDAs means (i) the New Drug Application N074973 for the 50mg/5mL product and (ii) the New Drug Application N074974 for the 25mg/5mL product (which is discontinued but not withdrawn), including, in each case, amendments, supplements, records, data, reports, correspondence, and documentation of related communications with the FDA, and any other submissions or filings to or with the FDA regarding the foregoing.
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Product NDAs means the NDAs owned by Indevus as of the Effective Date relating to Trospium Twice-Daily (No. 21-595) and Trospium Once-Daily (No. 22-103), together with all amendments, supplements and updates thereto, as well as the corresponding INDs (with respect to Trospium Twice-Daily, IND 61,381, and with respect to Trospium Once-Daily, IND 71,305).
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Product NDAs means the NDAs set forth on Annex 1.1(g).
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Related to Product NDAs

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

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

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

  • Final Product means a product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.

  • Product Labeling means, with respect to a Licensed Product in a country or other jurisdiction in the Territory, (a) the Regulatory Authority-approved full prescribing information for such Licensed Product for such country or other jurisdiction, including any required patient information, and (b) all labels and other written, printed, or graphic matter upon a container, wrapper, or any package insert utilized with or for such Licensed Product in such country or other jurisdiction.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • WTO GPA country end product means an article that—

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • Aerosol product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

  • Commercial Product means any such product as defined in FAR 2.101.

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

  • Approved Product means any water fitting, plumbing product, material or component which is the subject of an existing WRAS Approval;

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • 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.

  • 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:

  • Pharmaceutical Product shall have the meaning ascribed to such term in Section 3.1(hh).

  • Product Data are illustrations, standard schedules, performance charts, instructions, brochures, diagrams, and other information furnished by the Contractor to illustrate materials or equipment for some portion of the Work.

  • Product Approval means the approval of a Governmental Authority necessary for the marketing and sale of the Product in a given country or regulatory jurisdiction, which may include the approval of an MAA (but shall not include any Pricing Approvals).

  • Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.

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

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • Finished Products means any one or more of the following petroleum oils, or a mixture or combination of these oils, to be used without further processing except blending by mechanical means: