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 and “Product ANDAs” mean the NDAs and ANDAs identified in Schedule 1.1(b).
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Examples of Product NDAs in a sentence

  • Such authorization shall include the right of reference to such DMFs by all of the INDs and Product NDAs submitted under this Section 8.

  • The costs incurred by USL in compiling and preparing Product NDAs and any and all other regulatory documents for the Product in the Territory shall be considered part of USL’s Development Costs.

  • Following the Date of Agreement, USL shall oversee, monitor, control and coordinate all regulatory actions, communications and filings with and submissions, including filings and submissions to INDs and Product NDAs for Product, and any supplements and amendments thereto, to the FDA and other Regulatory Authorities in the Territory with respect to all Product.

  • USL shall be responsible for diligently compiling and preparing all Product NDAs for the Territory and seeking, obtaining and maintaining Regulatory Approval for the Product in the Territory in accordance with the terms and conditions of this Agreement.

  • Without limiting the generality of the foregoing, USL will act as the Sponsor upon whom service of all processes, notices, orders, decisions, requirements, and other FDA communications shall be made with regard to all INDs and Product NDAs for the Product in the Territory.

  • On the NDA Transfer Date, Indevus shall submit to the FDA a letter authorizing the transfer of ownership from Indevus to Esprit of the Product NDAs. As soon as practicable after the submission of such letter and the receipt by Esprit of the FDA’s acknowledgment letter, Esprit shall execute and submit to the FDA a letter, accompanied by the Product NDA transfer letter referred to in the preceding sentence, acknowledging Esprit’s commitment to assume ownership of the Product NDAs.

  • 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.

  • Services will be scheduled and performed during regular business hours, Monday through Friday, 8:00 AM to 4:30 PM, excluding holidays.

  • 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.

  • Indevus hereby assigns to Esprit all right, title and interest in the Product NDAs, effective as of the NDA Transfer Date.


More Definitions of Product NDAs

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 for Product as set forth on Annex 3.
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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 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 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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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) meets 1 or more of the following:

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

  • DMF means a drug master file, as provided for in 21 CFR § 314.420 or similar submission to or file maintained with the FDA or other Governmental Authority or Regulatory Authority that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

  • Final Product means a reasonably homogenous cannabis product in its final packaged form created using the same standard operating procedures and the same formulation.

  • Product Labeling means (a) the full prescribing information for the Product approved by the applicable Regulatory Authority, and (b) all labels and other written, printed or graphic information included in or placed upon any container, wrapper or package insert used with or for the Product.

  • 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 Abbreviated New Drug Application.

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

  • Licensed Product means any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms.

  • Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • NDA means a New Drug Application, as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding foreign application, registration or certification.

  • 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: