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• An Abbreviated New Drug Application (ANDA) contains data that, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Generic drug applications are called "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the innovator drug). Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.

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  American Psychological Association (APA)

  Abbreviated New Drug Application (ANDA). (n.d.). [email protected] Glossary of Terms. Retrieved March 28, 2023, from website: http://www.expertglossary.com/definition/abbreviated-new-drug-application-anda.

  Chicago Manual of Style (CMS)

  Abbreviated New Drug Application (ANDA). www.fda.gov. [email protected] Glossary of Terms. FDA. http://www.expertglossary.com/definition/abbreviated-new-drug-application-anda (accessed: March 28, 2023).

  Modern Language Association (MLA)

  "Abbreviated New Drug Application (ANDA)." [email protected] Glossary of Terms. FDA. 28 March. 2023 http://www.expertglossary.com/definition/abbreviated-new-drug-application-anda.

• Browse Related Terms: Abbreviated New Drug Application (ANDA), Abbreviated New Drug Application (ANDA) Number, application, Application Number, Approval Letter, Biologic License Application (BLA), Company, FDA Application Number, New Drug Application (NDA), New Drug Application (NDA) Number, Product Number, Review, Review Classification

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• This six-digit number is assigned by FDA staff to each application for approval to market a generic drug in the United States.

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  Cite Definition for Abbreviated New Drug Application (ANDA) Number

  American Psychological Association (APA)

  Abbreviated New Drug Application (ANDA) Number. (n.d.). [email protected] Glossary of Terms. Retrieved March 28, 2023, from website: http://www.expertglossary.com/definition/abbreviated-new-drug-application-anda-number.

  Chicago Manual of Style (CMS)

  Abbreviated New Drug Application (ANDA) Number. www.fda.gov. [email protected] Glossary of Terms. FDA. http://www.expertglossary.com/definition/abbreviated-new-drug-application-anda-number (accessed: March 28, 2023).

  Modern Language Association (MLA)

  "Abbreviated New Drug Application (ANDA) Number." [email protected] Glossary of Terms. FDA. 28 March. 2023 http://www.expertglossary.com/definition/abbreviated-new-drug-application-anda-number.

• Browse Related Terms: Abbreviated New Drug Application (ANDA), Abbreviated New Drug Application (ANDA) Number, application, Application Number, Approval Letter, Biologic License Application (BLA), Company, FDA Application Number, New Drug Application (NDA), New Drug Application (NDA) Number, Product Number, Review, Review Classification

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• An active ingredient is any component that provides pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or animals.

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  American Psychological Association (APA)

  Active Ingredient. (n.d.). [email protected] Glossary of Terms. Retrieved March 28, 2023, from website: http://www.expertglossary.com/definition/active-ingredient.

  Chicago Manual of Style (CMS)

  Active Ingredient. www.fda.gov. [email protected] Glossary of Terms. FDA. http://www.expertglossary.com/definition/active-ingredient (accessed: March 28, 2023).

  Modern Language Association (MLA)

  "Active Ingredient." [email protected] Glossary of Terms. FDA. 28 March. 2023 http://www.expertglossary.com/definition/active-ingredient.

• Browse Related Terms: Active Ingredient, agonist, antagonist, Biological Product, Buprenorphine, Detoxification, Drug, methadone, Opioid, Therapeutic Biological Product

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• A chronic, relapsing disease characterized by compulsive drug seeking and use, despite serious adverse consequences, and by long-lasting changes in the brain.

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  American Psychological Association (APA)

  addiction. (n.d.). NIH Prescription Drug Abuse Glossary. Retrieved March 28, 2023, from website: http://www.expertglossary.com/definition/addiction.

  Chicago Manual of Style (CMS)

  addiction. www.drugabuse.gov. NIH Prescription Drug Abuse Glossary. National Institute on Drug Abuse. http://www.expertglossary.com/definition/addiction (accessed: March 28, 2023).

  Modern Language Association (MLA)

  "addiction." NIH Prescription Drug Abuse Glossary. National Institute on Drug Abuse. 28 March. 2023 http://www.expertglossary.com/definition/addiction.

• Browse Related Terms: addiction, central nervous system, Comorbidity, Dopamine, Norepinephrine, Physical Dependence, Stimulants, Tolerance, Withdrawal

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• A chemical entity that binds to a receptor and activates it, mimicking the action of the natural (or abused) substance that binds there.

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  American Psychological Association (APA)

  agonist. (n.d.). NIH Prescription Drug Abuse Glossary. Retrieved March 28, 2023, from website: http://www.expertglossary.com/definition/agonist.

  Chicago Manual of Style (CMS)

  agonist. www.drugabuse.gov. NIH Prescription Drug Abuse Glossary. National Institute on Drug Abuse. http://www.expertglossary.com/definition/agonist (accessed: March 28, 2023).

  Modern Language Association (MLA)

  "agonist." NIH Prescription Drug Abuse Glossary. National Institute on Drug Abuse. 28 March. 2023 http://www.expertglossary.com/definition/agonist.

• Browse Related Terms: Active Ingredient, agonist, antagonist, Biological Product, Buprenorphine, Detoxification, Drug, methadone, Opioid, Therapeutic Biological Product

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• A chemical entity that binds to a receptor and blocks its activation. Antagonists prevent the natural (or abused) substance from activating its receptor.

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  American Psychological Association (APA)

  antagonist. (n.d.). NIH Prescription Drug Abuse Glossary. Retrieved March 28, 2023, from website: http://www.expertglossary.com/definition/antagonist.

  Chicago Manual of Style (CMS)

  antagonist. www.drugabuse.gov. NIH Prescription Drug Abuse Glossary. National Institute on Drug Abuse. http://www.expertglossary.com/definition/antagonist (accessed: March 28, 2023).

  Modern Language Association (MLA)

  "antagonist." NIH Prescription Drug Abuse Glossary. National Institute on Drug Abuse. 28 March. 2023 http://www.expertglossary.com/definition/antagonist.

• Browse Related Terms: Active Ingredient, agonist, antagonist, Biological Product, Buprenorphine, Detoxification, Drug, methadone, Opioid, Therapeutic Biological Product

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• See New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologic License Application (BLA).
  FDA - Cite This Source - This Definition
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  Cite Definition for application

  American Psychological Association (APA)

  application. (n.d.). [email protected] Glossary of Terms. Retrieved March 28, 2023, from website: http://www.expertglossary.com/definition/application.

  Chicago Manual of Style (CMS)

  application. www.fda.gov. [email protected] Glossary of Terms. FDA. http://www.expertglossary.com/definition/application (accessed: March 28, 2023).

  Modern Language Association (MLA)

  "application." [email protected] Glossary of Terms. FDA. 28 March. 2023 http://www.expertglossary.com/definition/application.

• Browse Related Terms: Abbreviated New Drug Application (ANDA), Abbreviated New Drug Application (ANDA) Number, application, Application Number, Approval Letter, Biologic License Application (BLA), Company, FDA Application Number, New Drug Application (NDA), New Drug Application (NDA) Number, Product Number, Review, Review Classification

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• See FDA Application Number
  FDA - Cite This Source - This Definition
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  Cite Definition for Application Number

  American Psychological Association (APA)

  Application Number. (n.d.). [email protected] Glossary of Terms. Retrieved March 28, 2023, from website: http://www.expertglossary.com/definition/application-number.

  Chicago Manual of Style (CMS)

  Application Number. www.fda.gov. [email protected] Glossary of Terms. FDA. http://www.expertglossary.com/definition/application-number (accessed: March 28, 2023).

  Modern Language Association (MLA)

  "Application Number." [email protected] Glossary of Terms. FDA. 28 March. 2023 http://www.expertglossary.com/definition/application-number.

• Browse Related Terms: Abbreviated New Drug Application (ANDA), Abbreviated New Drug Application (ANDA) Number, application, Application Number, Approval Letter, Biologic License Application (BLA), Company, FDA Application Number, New Drug Application (NDA), New Drug Application (NDA) Number, Product Number, Review, Review Classification

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• The approval history is a chronological list of all FDA actions involving one drug product having a particular FDA Application number (NDA). There are over 50 kinds of approval actions including changes in the labeling, a new route of administration, and a new patient population for a drug product.

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  Cite Definition for Approval History

  American Psychological Association (APA)

  Approval History. (n.d.). [email protected] Glossary of Terms. Retrieved March 28, 2023, from website: http://www.expertglossary.com/definition/approval-history.

  Chicago Manual of Style (CMS)

  Approval History. www.fda.gov. [email protected] Glossary of Terms. FDA. http://www.expertglossary.com/definition/approval-history (accessed: March 28, 2023).

  Modern Language Association (MLA)

  "Approval History." [email protected] Glossary of Terms. FDA. 28 March. 2023 http://www.expertglossary.com/definition/approval-history.

• Browse Related Terms: Approval History, Discontinued Drug Product, FDA Action Date, label, Marketing Status, Reference Listed Drug (RLD), Route, Supplement, Supplement Number, Supplement Type, Tentative Approval

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• An official communication from FDA to a new drug application (NDA) sponsor that allows the commercial marketing of the product.

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  American Psychological Association (APA)

  Approval Letter. (n.d.). [email protected] Glossary of Terms. Retrieved March 28, 2023, from website: http://www.expertglossary.com/definition/approval-letter.

  Chicago Manual of Style (CMS)

  Approval Letter. www.fda.gov. [email protected] Glossary of Terms. FDA. http://www.expertglossary.com/definition/approval-letter (accessed: March 28, 2023).

  Modern Language Association (MLA)

  "Approval Letter." [email protected] Glossary of Terms. FDA. 28 March. 2023 http://www.expertglossary.com/definition/approval-letter.

• Browse Related Terms: Abbreviated New Drug Application (ANDA), Abbreviated New Drug Application (ANDA) Number, application, Application Number, Approval Letter, Biologic License Application (BLA), Company, FDA Application Number, New Drug Application (NDA), New Drug Application (NDA) Number, Product Number, Review, Review Classification