Drug

Drug terms

1. Abbreviated New Drug Application (ANDA) (ANDA) An Abbreviated New Drug Application (ANDA) contains data that, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs…
2. Abbreviated New Drug Application (ANDA) Number (ANDA) This six-digit number is assigned by FDA staff to each application for approval to market a generic drug in the United States.
3. Active Ingredient An active ingredient is any component that provides pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or…
4. Addiction Uncontrollable craving, seeking, and use of a substance such as a drug or alcohol.
5. agonist A drug that triggers an action from a cell or another drug.
6. antagonist In medicine, a substance that stops the action or effect of another substance. For example, a drug that blocks the stimulating effect of estrogen on a…
7. Application Under the Equal Credit Opportunity Act (ECOA), an oral or written request for an extension of credit that is made in accordance with the procedures…
8. Application Number See FDA Application Number
9. Approval History The approval history is a chronological list of all FDA actions involving one drug product having a particular FDA Application number (NDA).
10. Approval Letter An official communication from FDA to a new drug application (NDA) sponsor that allows the commercial marketing of the product.
11. Barbiturate (bar-BICH-u-rit) A drug used to treat insomnia, seizures, and convulsions, and to relieve anxiety and tension before surgery.
12. Benzodiazepine A type of CNS depressant prescribed to relieve anxiety and sleep problems. Valium and Xanax are among the most widely prescribed medications.
13. Biologic License Application (BLA) (BLA) Biological products are approved for marketing under the provisions of the Public Health Service (PHS) Act.
14. Biological Product Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and…
15. Brand Name Drug A brand name drug is a drug marketed under a proprietary, trademark-protected name.
16. Buprenorphine A mixed opiate agonist/antagonist medication approved by the FDA in October 2002 for the treatment of opioid addiction (e.g., heroin).
17. Central Nervous System (SEN-trul NER-vus SIS-tem) The brain and spinal cord. Also called CNS.
18. Chemical Type The Chemical Type represents the newness of a drug formulation or a new indication for an existing drug formulation.
19. CNS Depressants A class of drugs that slow CNS function (also called sedatives and tranquilizers), some of which are used to treat anxiety and sleep disorders; includes…
20. Comorbidity The condition of having two or more diseases at the same time.
21. Company The company (also called applicant or sponsor) submits an application to FDA for approval to market a drug product in the United States.
22. Detoxification A process in which the body rids itself of a drug (or its metabolites). During this period, withdrawal symptoms can emerge that may require medical…
23. Discontinued Drug Product Products listed in Drugs@FDA as "discontinued" are approved products that have never been marketed, have been discontinued from marketing, are for…
24. Dopamine A brain chemical, classified as a neurotransmitter, found in regions that regulate movement, emotion, motivation, and pleasure.
25. Dosage Form A dosage form is the physical form in which a drug is produced and dispensed, such as a tablet, a capsule, or an injectable.
26. drug Any substance, other than food, that is used to prevent, diagnose, treat or relieve symptoms of a disease or abnormal condition.
27. Drug Product The finished dosage form that contains a drug substance, generally, but not necessarily in association with other active or inactive ingredients.
28. FDA Action Date The action date tells when an FDA regulatory action, such as an original or supplemental approval, took place.
29. FDA Application Number This number, also known as the NDA (New Drug Application) number, is assigned by FDA staff to each application for approval to market a new drug in the…
30. Generic Drug A drug that is similar to a name-brand drug but not covered by original patents and therefore cheaper.
31. label The FDA approved label is the official description of a drug product which includes indication (what the drug is used for); who should take it; adverse…
32. Marketing Status Marketing status indicates how a drug product is sold in the United States. Drug products in Drugs@FDA are identified as: Prescription Over-the-counter…
33. Medication Guide A medication guide contains information for patients on how to safely use a drug product.
34. Methadone (MEH-thuh-DONE) A morphine-like drug used to treat severe pain and to prevent withdrawal symptoms in patients who are addicted to heroin or other opiates.
35. Narcolepsy A disorder characterized by uncontrollable episodes of deep sleep.
36. New Drug Application (NDA) (NDA) When the sponsor of a new drug believes that enough evidence on the drug's safety and effectiveness has been obtained to meet FDA's requirements for…
37. New Drug Application (NDA) Number (NDA) This six digit number is assigned by FDA staff to each application for approval to market a new drug in the United States.
38. New Molecular Entity (NME) (NME) A New Molecular Entity is an active ingredient that has never before been marketed in the United States in any form.
39. Norepinephrine (NOR-ep-ih-NEF-rin) A chemical made by some nerve cells and in the adrenal gland.
40. Opioid (OH-pee-OYD) A drug used to treat moderate to severe pain. Opioids are similar to opiates such as morphine and codeine, but they do not contain and are…
41. Over-the-Counter Drugs (OTC) (OTC) FDA defines OTC drugs as safe and effective for use by the general public without a doctor's prescription.
42. Patient Package Insert (PPI) (PPI) A patient package insert contains information for patients' understanding of how to safely use a drug product.
43. Pharmaceutical Equivalents FDA considers drug products to be pharmaceutical equivalents if they meet these three criteria: they contain the same active ingredient(s) they are of the…
44. Physical Dependence (FIH-zih-kul dee-PEN-dents) A condition in which a person takes a drug over time, and unpleasant physical symptoms occur if the drug is suddenly stopped…
45. Polydrug Abuse The abuse of two or more drugs at the same time, such as CNS depressants and alcohol.
46. Prescription Drug Abuse The use of a medication without a prescription; in a way other than as prescribed; or for the experience or feeling elicited.
47. Prescription Drug Product A prescription drug product requires a doctor's authorization to purchase.
48. Product Number A product number is assigned to each drug product associated with an NDA (New Drug Application).
49. Psychotherapeutics Drugs that have an effect on the function of the brain and that often are used to treat psychiatric/neurologic disorders; includes opioids, CNS…
50. Reference Listed Drug (RLD) (RLD) A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent.
51. Respiratory Depression Slowing of respiration (breathing) that results in the reduced availability of oxygen to vital organs.
52. Review A review is the basis of FDA's decision to approve an application. It is a comprehensive analysis of clinical trial data and other information prepared by…
53. Review Classification The NDA and BLA classification system provides a way of describing drug applications upon initial receipt and throughout the review process and…
54. route A route of administration is a way of administering a drug to a site in a patient.
55. Sedatives Drugs that suppress anxiety and promote sleep; the NSDUH classification includes benzodiazepines, barbiturates, and other types of CNS depressants.
56. Stimulants A class of drugs that enhances the activity of monamines (such as dopamine) in the brain, increasing arousal, heart rate, blood pressure, and respiration…
57. Strength The strength of a drug product tells how much of the active ingredient is present in each dosage.
58. Supplement A supplement is an application to allow a company to make changes in a product that already has an approved new drug application (NDA).
59. Supplement Number A supplement number is associated with an existing FDA New Drug Application (NDA) number.
60. Supplement Type Companies are allowed to make changes to drugs or their labels after they have been approved.
61. Tentative Approval If a generic drug product is ready for approval before the expiration of any patents or exclusivities accorded to the reference listed drug product, FDA…
62. Therapeutic Biological Product A therapeutic biological product is a protein derived from living material (such as cells or tissues) used to treat or cure disease.
63. Therapeutic Equivalence (TE) (TE) Drug products classified as therapeutically equivalent can be substituted with the full expectation that the substituted product will produce the same…
64. Therapeutic Equivalence (TE) Codes (TE) The coding system for therapeutic equivalence evaluations allows users to determine whether FDA has evaluated a particular approved product as…
65. Tolerance A condition in which higher doses of a drug are required to produce the same effect achieved during initial use; often associated with physical dependence.
66. Tranquilizers Drugs prescribed to promote sleep or reduce anxiety; the NSDUH classification includes benzodiazepines, barbiturates, and other types of CNS depressants.
67. Withdrawal A withdrawal is money you take out of your banking, brokerage firm, or other accounts.