Dosage Forms definition

Dosage Forms means the final dosage form in which a Pharmaceutical Product will be administered to a human or animal.
Dosage Forms means the three (3) dosage forms in which Products may be developed, comprised of (i) topical (including any and all external applications); (ii) oral (including any ingestible form); and (iii) injectable (which shall include any dosage form other than topical or oral, including, without limitation, suppository, patch, depot, implant or pessary). When used in the singular, "Dosage Form" shall mean any of the three Dosage Forms.

Examples of Dosage Forms in a sentence

  • The sole decision to recall the Packaged Dosage Forms and/or the Packaged Device shall reside with Aradigm, pursuant to Aradigm’s written policy.

  • Subject to the terms and conditions of this Agreement, EURAND hereby grants to SCANDIPHARM an exclusive royalty-bearing license within the Territory to use the Product to register, package, market and sell the Finished Dosage Forms.

  • Upon written request, SCANDIPHARM will inform EURAND about any useful marketing literature concerning the sales of the Finished Dosage Forms in the Territory.

  • Notwithstanding any provision in this Agreement to the contrary, SCANDIPHARM shall have no obligation to apply for or obtain Applicable Permits in any country in the Territory if such registration or approval is reasonably deemed to be unnecessary to market the Finished Dosage Forms in such country.

  • Additionally, each Party shall immediately notify the Authorized Quality Representative of the other Party of any information it receives relating to the quality of the Packaged Dosage Forms and/or Packaged Device in human clinical trials, which in the notifying Party’s judgment, relates to the Manufacturing process of the Packaged Dosage Forms and/or Packaged Device.

  • Aradigm will be responsible for all regulatory communication as pertains to Packaged Dosage Forms and/or Packaged Device.

  • Packaged Dosage Forms containing controlled substances shall be shipped as soon as practicable.

  • For clarity, Aradigm will be responsible for developing and conducting analytical testing for all non-iDMS identical materials and components and cleaning agents including API and Other Excipients and testing to verify cleaning of Novo Nordisk Delivery Technologies, Inc.’s facilities after manufacture of Dosage Forms.

  • No Batch of Packaged Dosage Forms or Packaged Devices shall be deemed to have been accepted until the quality control sample and associated documentation related to such Batch have been accepted by Aradigm pursuant to Section 5.4, such acceptance not to be unreasonably withheld or delayed.

  • The Parties have the responsibility to notify each other within twenty-four (24) hours of a situation which could be reasonably expected to result in a recall and/or withdrawal of Packaged Dosage Forms and/or Packaged Device.

Related to Dosage Forms

  • 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.

  • 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;

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

  • 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:

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

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • 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.

  • Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.

  • Shipment means a volume of products offered to and accepted by Carrier for transportation.

  • processed products means goods placed under a processing procedure which have undergone processing operations;

  • Labeling means all labels and other written, printed, or graphic matter on an article or any of its

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

  • Formulation means the combination of various ingredients designed to render the product useful and effective for the purpose claimed, or the form of pesticide as purchased by users;

  • Additional Product means any Product identified as such in the Product Terms and chosen by Enrolled Affiliate under this Enrollment.

  • 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.

  • Licensed Processes means processes which, in the course of being practiced, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

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

  • Active Pharmaceutical Ingredient or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”), elvitegravir (“EVG”), and cobicistat (“COBI”).

  • Drug sample means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

  • API means American Petroleum Institute.

  • ingredient means any substance, including a food additive used in the manufacture or preparation of food and present in the final product, possibly in a modified form;

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

  • Inert ingredient means an ingredient which is not an active ingredient.

  • Recycled product means a product containing recovered material, or post-consumer recovered material, or both.

  • Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

  • Red Hat Products means Software, Services, Subscriptions and other Red Hat branded offerings made available by Red Hat.