[Dry goods] Drugs@FDA proprietary vocabulary interpretation
ANDA: Abbreviated New Drug Application Simplifies New Drug Application
The Simplified New Drug Application (ANDA) contains data submitted to the FDA Drug Evaluation Center (CED) Office of Generic Drugs (OGD) for review and full approval of a generic drug. Generic applications are referred to as “simplifications†because they are not required to submit preclinical (animal) research and clinical (human) research data to establish safety and effectiveness.
Abbreviated New Drug Application (ANDA) Number Simplifies New Drug Application Number
A six-digit number assigned by the FDA for each generic drug application approved for listing in the United States.
Active Ingredient Active Ingredients
An active ingredient is any component that provides pharmacological activity or other process for diagnosing, curing, ameliorating, treating a disease, or affecting the structure or function of a human or animal body.
Approval History approved history
The approved history is a FDA-listed list of all the actions of a product with an application number over time. There are more than 50 FDA actions available, including label changes, new routes of administration, and new patient populations.
Application
See New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologic License Application (BLA)
Approval Letter approved letter
An approved letter is an official document that the FDA informs the drug application sponsor to allow the drug to be commercialized.
Application Number Application Number
See FDA Application Number
Biologic License Application (BLA) Biological Product License Application
Biological products are approved for listing in accordance with the terms of the Public Health Service Act. The bill requires producers of biologics in the state to hold permits. Information on detailed manufacturing processes, chemistry, pharmacology, clinical pharmacology, and medical effects is required to submit a biologics license application. If the submitted information meets FDA requirements, the application will be approved for sale.
Biological Product
Biological products include a wide range of products including vaccines, blood and blood components, allergens, stem cells, gene therapy, tissue and recombinant therapeutic proteins. Biologics may contain sugars, proteins, nucleic acids or complex compositions of these substances, as well as living entities such as cells and tissues. Biologics are isolated from a wide range of natural sources, such as humans, animals or microorganisms, and can be produced by biotechnological or other epoch-making techniques. Biologic- and cell-based biomass (Biologics) is often in the forefront of biological research and may play a role that other treatments cannot play in a variety of medical settings. In summary, the term "drugs" encompasses therapeutic biological products.
Brand Name Drug
A trade name drug refers to a drug sold under a proprietary name and a protected trade name.
Chemical Type Chemical Type
The “Chemical Type†is no longer used in Drugs@FDA. The Submission Type previously specified by the FDA for a New Drug Application (NDA), such as "Type 1" means a new molecular entity (NME).
Company
The company (also known as the "Applicant" or "Sponsor") submits a drug listing application to the FDA.
Discontinued Drug Product
Drugs classified as “discontinued†in Drug@FDA are approved and unlisted drugs, such as military use, export-only or Other Products that are not withdrawn from the market for safety effectiveness.
Dosage Form
The dosage form is a physical form for the production or dispersion of the drug, such as tablets, capsules, and injections.
Drug drug
The definition of the drug is as follows:
a substance recognized by an official pharmacopoeia or formulary;
a substance used to diagnose, cure, alleviate, treat or prevent a disease;
a substance used to affect the structure or any function of the body other than food;
a component for medical articles other than the component parts of the device and the device;
Biological products are subject to the same laws and regulations as drugs in the definition of drugs, but there are differences in the production process.
Drug Product
A drug is a finished drug-containing final dosage form that is often associated with other active and inactive ingredients.
FDA Action Date FDA Action Date
The time at which the FDA's actions, such as original approval or supplemental approval, occur.
FDA Application Number FDA Application Number
The FDA assigns a unique number to each US-listed drug application. The types of application numbers are: NDA, ANDA, and BLA. A drug may have more than one application number if it has different dosage forms and routes of administration.
Generic Drug generics
The generic drug is identical to the generic drug in terms of dosage form, safety, dosage, method of use, quality, performance and usage. Before approving a generic drug, the FDA requires a number of rigorous tests and procedures to ensure that generic drugs can replace generic drugs. The FDA is based on a special scientific evaluation of therapeutic equivalence. The law stipulates that generic drugs must contain the same amount of the same active ingredient as the generic drug. The effect of the drug evaluated as "therapeutic equivalence" is expected to be equivalent to that of the drug name.
Label label
The FDA-approved label is an official description of the drug, including indications, applicable population, adverse events (side effects), medication guidance during pregnancy, medication guidance for children, medication guidance for other special populations, safety information Wait. The label is usually inside the medicine package.
Marketing Status
The market status indicates how the drug is sold in the US. The market status of Drugs@FDA drugs is divided into four categories:
Prescription, over-the-counter (OTC), intermittent medicine, provisional approval.
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