Dosage Strength definition

Dosage Strength meanss the amount of Peanut Flour expressed as mg peanut protein in a capsule or sachet of Product.
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Dosage Strength means a formulation of MT 400 containing [***] mg sumatriptan base or [***] mg sumatriptan (1:1) succinate combined with [***] mg naproxen sodium.
Sample 1
Dosage Strength means the dosage strength with respect to the Product as set forth in the Product Schedule. 1.35 “Dossier” means a copy of the documents submitted to the FDA in support of the NDA for the Product including scientific and technical data relating to the Product and other related information that may be required for Pharmanovia’s submissions for Regulatory Approvals in the Territory; for the avoidance of doubt this includes but not limited to any raw technical data supporting the NDA during pre-assessment and assessment phases. 1.36 “Excluded Claim” has the meaning set forth in Section 14.12.8. 1.37 “Effective Date” has the meaning set forth in the Preamble of this Agreement. 1.38 “Exchange Rate” has the meaning set forth in Section 7.2. 1.39 “Executive Officer” has the meaning set forth in Section 14.12.2. 1.40 “FCPA” means the U.S. Foreign Corrupt Practices Act (15 U.S.C. Section 78dd-1, et. seq.), as amended and as may be further amended after the Effective Date, and any equivalent non-U.S. regulations or standards, if and as applicable during the Term. 1.41 “FDA” means the United States Food and Drug Administration, and any of its successor agencies or departments. 1.42 “Field” means the field with respect to the Product as set forth in the Product Schedule. 1.43 “First Commercial Sale” means with respect to a country in the Territory, the first sale of the Product to a Third Party by Pharmanovia (or any Affiliate or subcontractor of Pharmanovia authorized by Pharmanovia pursuant to this Agreement) within such country in the Territory after Regulatory Approval (and where applicable, (i) pricing or reimbursement approval in such country and (ii) labeling approval) for the Product has been obtained in such country. 1.44 “Force Majeure” has the meaning set forth in Section 14.7. 1.45 “GAAP” means generally accepted accounting principles set forth from time to time in the opinions and pronouncements of the Accounting Principles Board and the American
Sample 1

Examples of Dosage Strength in a sentence

  • Dosing and Administration for Adult Patients Patient PopulationRecommended Dosage Strength and FrequencyAdult RA, AS, and PsA Patients50 mg weeklyAdult PsO PatientsStarting Dose: 50 mg twice weekly for 3 months Maintenance Dose: 50 mg once weekly See the ERELZI (etanercept-szzs) “Instructions for Use” insert for detailed information on injection site selection and dose administration.

  • Dosing and Administration for Adult Patients Patient PopulationRecommended Dosage Strength and FrequencyAdult RA, AS, and PsA50 mg weeklyAdult PsOStarting Dose: 50 mg twice weekly for 3 months Maintenance Dose: 50 mg once weekly See the ERELZI (etanercept-szzs) “Instructions for Use” insert for detailed information on injection site selection and dose administration.

  • Dosing and Administration for Adult Patients Patient PopulationRecommended Dosage Strength and FrequencyAdult RA and AS50 mg weekly See the ERELZI (etanercept-szzs) “Instructions for Use” insert for detailed information on injection site selection and dose administration.

  • MSRx shall have the right to access, use and reference the NDA, including any and all data and other information directly relating thereto solely for the purpose of developing and obtaining Regulatory Approvals to market and sell products outside of the Territory, the Indication and/or the Dosage Strength.

  • The first such forecast for each Product by Dosage Strength shall be delivered by Galena to MSRx no later than thirty (30) days after the Effective Date of the Agreement and thereafter on the first Business Day of each February, May, August and November of each calendar year during the Term for the immediately succeeding calendar quarter.

  • Each such purchase order shall designate the quantity of Product by Dosage Strength ordered and the requested date of delivery of the Product to Galena or to Galena’s Affiliates or any Third Party designated by Galena.

  • Parties shall negotiate in good faith and agree on a reasonable forecasting process for 2.5 mg Dosage Strength Product a reasonable time prior to approval of such Product.

  • To Seller’s Knowledge, other than the Licensed Intellectual Property, Seller and its Affiliates do not own or have license rights to any Intellectual Property Rights in the Buyer Territory that would be infringed, violated or misappropriated by use, offer for sale or sale (by an unauthorized Third Party) of Product the 2.5 mg Dosage Strength or the [***] Product in the Buyer Territory, as the Product Business is currently being conducted.

  • Having a senior physician involved with the initial care of all of these patients would presumably result in an even greater percentage being able to be safely discharged home [13].Interviews with junior physicians, as well as reports from those involved in physician education support, reveal that most junior physicians believe their experience in the FAM is very valuable.

  • Seller and its Affiliates have made all necessary material filings and received all necessary material approvals and consents for the conduct of such Phase IV clinical trials and 2.5 mg Clinical Trials from the necessary Governmental Authorities and, to Seller’s Knowledge, there is no Litigation pending or threatened by such Governmental Authorities to suspend or terminate any ongoing clinical trials for the Product or the 2.5 mg Dosage Strength in the Buyer Territory.


More Definitions of Dosage Strength

Dosage Strength means the 0xx, 0.0xx, 10mg, 12.5 mg, 15mg, 17.5mg, and 20mg dosage strengths of the Product. 1.4 “Field” means the treatment of prolonged or acute, convulsive seizures in all ages, or such other definition that is consistent with the foregoing and agreed upon in good faith by the Parties in writing). 1.5 “Product” means diazepam buccal film. 1.6 “Manufacturing Facility” means, as of the Effective Date, Aquestive’s manufacturing site located at 0000 Xxxxxxxxx Xxxxx, Xxxxxxx, Xxxxxxx (XX) 00000, Xxxxxx Xxxxxx (XXX), FDA Establishment Number 0000000000. 1.7 “Territory” means: (i) the countries of the European Union (as of the Effective Date), Sweden, Switzerland and Norway; (ii) the United Kingdom (England, Scotland, Wales and Northern Ireland); and (iii) the Middle East and North Africa (Algeria, Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Qatar, Saudi Arabia, Syria, Tunisia, United Arab Emirates and Yemen).
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Dosage Strength means the 5mg, 7.5mg, 10mg, 12.5 mg, 15mg, 17.5mg, and 20mg dosage strengths of the Product. 1.4 “Field” means the treatment of (i) prolonged or acute, convulsive seizures in all ages, or such other definition that is consistent with the foregoing and agreed upon in good faith by the Parties in writing, and (ii) the medical indications set forth in Pharmanovia’s present approved label for Valium™(diazepam) in all territories, including those where there is currently not a Valium approved product. 1.5 “Product” means diazepam buccal film. 1.6 “Manufacturing Facility” means, as of the Effective Date, Aquestive’s manufacturing site located at 0000 Xxxxxxxxx Xxxxx, Xxxxxxx, Xxxxxxx (XX) 00000, Xxxxxx Xxxxxx (XXX), FDA Establishment Number 3004395604. 1.7 “Territory” means all of: 1.
Sample 1
Dosage Strength means a [* *].
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Dosage Strength means the 50mg dosage strength of the Product. 1.39 “Drug Product” means a chemical drug product as defined in Applicable Law for administration to human subjects. 1.40 “Excluded Claim” has the meaning set forth in Section 15.12.8. 1.41 “Effective Date” has the meaning set forth in the Preamble of this Agreement. 1.42 “Events” means the events set forth in Section 8.1. 1.43 “Executive Officer” has the meaning set forth in Section 15.12.2. 1.44 “Field” means administration of the Product for Amyotrophic Lateral Sclerosis. 1.45 “First Commercial Sale” means the first sale of the Product to a Third Party by Haisco or its Affiliates or agents within the Territory after receipt of Regulatory Approval; provided, that, the following shall not constitute a First Commercial Sale: (a) any sale to an Affiliate or sublicensee (unless the Affiliate or sublicensee is the last entity in the distribution chain of the Product); (b) any use of the Product in clinical trials or other research or Development activities; or (c) the disposal or transfer of the Product for a bona fide charitable purpose, without consideration, including for any compassionate use and/or as “named patient sales”. 1.46 “Force Majeure” has the meaning set forth in Section 15.7. 1.47 “Generic Product” means, with respect to the Product in the Field in the Territory, any Drug Product (other than the Product) that: (a) contains the API as the active pharmaceutical ingredient; and (b) is approved by the NMPA pursuant to an abbreviated application filed with the NMPA pursuant to the Applicable Law of the People’s Republic of China for which the Product is the Reference Listed Drug and which is not held in the name of Aquestive, Haisco or an Affiliate thereof, or sublicensee or subcontractor thereof.
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Related to Dosage Strength

  • Therapeutic care means services provided by licensed or certified speech pathologists, Occupational Therapists and Physical Therapists.

  • Radiopharmaceutical means any drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any non-radioactive reagent kit or radionuclide generator that is intended to be used in the preparation of any such substance, but does not include drugs such as carbon-containing compounds or potassium-containing salts that include trace quantities of naturally occurring radionuclides. The term also includes any biological product that is labeled with a radionuclide or intended solely to be labeled with a radionuclide.

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

  • Satellite Manufacturer means, with respect to any Satellite, the prime contractor and manufacturer of such Satellite.

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.

  • Stable in relation to land, means land form dimensions are or will be stable within tolerable limits now and in the foreseeable future. Stability includes consideration of geotechnical stability, settlement and consolidation allowances, bearing capacity (trafficability), erosion resistance and geochemical stability with respect to seepage, leachate and related contaminant generation.

  • Scale means the height, width and length of each building proposed within the development in relation to its surroundings;

  • Reference biological product means the single biological product licensed pursuant to 42 U.S.C.

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

  • Cannabis products means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • Cannabis product means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

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

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

  • Generic means that no specific brand or name shall be included as part of the specifications unless such a brand or name is required to identify the intent of a purchase, order or proposal.

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

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

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

  • Manufacturer means the person or body who is responsible to the approval authority for all aspects of the type approval process and for ensuring conformity of production. It is not essential that the person or body is directly involved in all stage of the construction of the vehicle, system, component or separate technical unit which is the subject of the approval process.

  • MANUFACTURERS means M/s and shall include their legal representatives, successors, and assigns.

  • Cannabis cultivator means any licensed person or entity that grows, cultivates, or produces cannabis in this State, and sells, and may transport, this cannabis to other cannabis cultivators, or usable cannabis to cannabis manufacturers, cannabis wholesalers, or cannabis retailers, but not to consumers.

  • Engine Manufacturer means CFM International, Inc.

  • Contract Manufacturer means a company that produces goods under contract for another company under the label or brand name of that company.

  • 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.

  • Viable means the stage of development of a human fetus at which there is a realistic possibility of maintaining and nourishing of a life outside the womb with or without temporary artificial life-sustaining support.

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