Abbreviated New Drug Application definition

Abbreviated New Drug Application or “ANDA” has the meaning set forth in the FD&C Act (21 U.S.C. § 355(b)(2), 21 U.S.C. § 355(j) and 21 C.F.R. § 314.3), as amended.
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Abbreviated New Drug Application or “ANDA” means an Abbreviated New Drug Application as defined in the FD&C Act and the regulations promulgated thereunder which references an NDA.
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Abbreviated New Drug Application means an abbreviated new drug application (including all applicable supplements and amendments that may be filed with respect thereto) filed with the FDA or any similar or successor applications or procedures seeking authorization and approval to Manufacture, package, ship, and sell a Product in the United States pursuant to the FDCA including an application under 21 U.S.C. § 355(j).
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Examples of Abbreviated New Drug Application in a sentence

  • In such a case, the appropriate submission would be an Abbreviated New Drug Application (ANDA) that cites the duplicate product as the reference listed drug.

  • A pharmacist may not select a drug product to substitute for a prescribed brand name drug unless such drug product is the generic equivalent of the prescribed brand name and has been manufactured under the Federal Food and Drug Administration's current Good Manufacturing Practice Regulations and meets U.S.P. or other official specifications, and has an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), or Antibiotic Form 5 or 6 Application approved by the U.

  • A generic drug is one that the FDA has approved under an Abbreviated New Drug Application (ANDA) and no New Drug Application (NDA) is on file.

  • A manufacturer seeking approval to sell a generic version of a brand drug may instead file an Abbreviated New Drug Application (“ANDA”).

  • Hospira, Inc., et al.; Withdrawal of Approval of One New Drug Application and Two Abbreviated New Drug Application.

  • Dermatological products marketed without FDA-approval via a New Drug Application, Abbreviated New Drug Application, or Biologics License Application.

  • The application number preceded by an “A” is an Abbreviated New Drug Application (ANDA or generic).

  • Wound care products, including oral rinses, marketed without FDA-approval via a New Drug Application, Abbreviated New Drug Application, or Biologics License Application.

  • The preferred brand drug list is updated periodically.o Any brand-name drug that is not on the preferred drug list is considered a non-preferred drug.o A generic drug is one that the FDA has approved under an Abbreviated New Drug Application (ANDA) and no New Drug Application (NDA) is on file.

  • It allows generic manufacturers to file an Abbreviated New Drug Application (“ANDA”) when seeking approval from the Food and Drug Administration (“FDA”) to market a generic version of an approved drug.


More Definitions of Abbreviated New Drug Application

Abbreviated New Drug Application means an abbreviated new drug application as defined in the FD&C Act (21 U.S.C. § 355(b)(2), 21 U.S.C. § 355(j) and 21 C.F.R. § 314.3), as amended, and any foreign equivalent of any of the foregoing.
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Abbreviated New Drug Application or “ANDA” means an Abbreviated New Drug Application filed with the FDA pursuant to § 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)).
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Abbreviated New Drug Application or “ ANDA ” means an Abbreviated New Drug Application as defined in the FD&C Act and the regulations promulgated thereunder which references an NDA.
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Abbreviated New Drug Application means an Abbreviated New Drug Application filed with the FDA to manufacture and/or sell a pharmaceutical product pursuant to the FDA's rules and regulations.
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Related to Abbreviated New Drug Application

  • Drug Application means a new drug application, an abbreviated drug application, or a product license application for any Product, as appropriate, as those terms are defined in the FDCA.

  • New Drug Application means a New Drug Application filed with the FDA in accordance with Applicable Law.

  • Drug Approval Application means, with respect to a Licensed Product in the Territory, an application for Regulatory Approval for such product in a country in the Territory. For purposes of clarity, Drug Approval Application shall include, without limitation, (a) an NDA or BLA (for U.S.) or MAA (for Europe); (b) a counterpart of an NDA, BLA or MAA in any country or region in the Territory; and (c) all supplements (including supplemental applications such as sNDAs) and amendments to the foregoing.

  • FFDCA means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).

  • Drug abuse means any pattern of pathological use of drugs that causes impairment in social or occupational functioning, or that produces physiological dependency evidenced by physical tolerance or by physical symptoms when it is withdrawn.

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • Planning Application means the application for [outline/full] planning permission dated [ ] bearing the Council’s reference number [ ];

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

  • State Abbreviation means the following:

  • FD&C Act means the U.S. Federal Food, Drug and Cosmetic Act, as amended, and the regulations promulgated thereunder.

  • Drug addiction means a disease characterized by a

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

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

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Regulatory Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

  • FDA means the United States Food and Drug Administration.

  • MHLW means the Ministry of Health, Labour and Welfare of Japan, or the successor thereto.

  • Registration Application means an application for registration of this Agreement as a planning agreement on the title of the Land pursuant to Section 7.6 of the Act in a form approved by the Registrar General;

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

  • Marketing Authorization Application or “MAA” means an application to the appropriate Regulatory Authority for approval to sell the Product (but excluding Pricing Approval) in any particular country or regulatory jurisdiction.

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • Drug means (i) articles or substances recognized in the official United States Pharmacopoeia

  • BLA means a Biologics License Application under the United States’ Public Health Services Act and Federal Food, Drug and Cosmetics Act, each as amended, and the regulations promulgated thereunder, or a comparable filing seeking Regulatory Approval in any country.

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • Prescription drug order means a lawful order of a practitioner for a drug or device for a specific patient that is communicated to a pharmacist.

  • New drug means: (i) any drug, except a new animal drug or an animal feed bearing or containing