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Drug and Device Resources. FDA Monthly Report Approved Drugs. FDA Search by number. Query Applicant Holder. Orange Book Application Number Search. Drugs@FDA Data Files. Below you will find a compressed data file of the Drugs@FDA database.

Drugs@FDA Data Files

It does not include the scripts (programming) we use to produce the online version of Drugs@FDA. We are providing this technical information for users who are familiar with working with databases or spreadsheets. All fields are separated by tab delimiters. Each table's primary key, data types, field lengths and nulls appear in the list below. While the official online application, Drugs@FDA, is updated daily, this data file is updated once per week, on Wednesday. Once you have downloaded the compressed file (drugsatfda.zip), you can unzip the file into 9 text tables.

We cannot offer guidance on how to construct your database design, as each user has different requirements or uses. Please note! Entity Relationship Diagram Drugs@FDA consists of 9 tables: Application Documents (AppDoc): Document addresses or URLs to letters, labels, reviews, Consumer Information Sheets, FDA Talk Papers, and other types. A Quick Guide to Understanding TE Codes. Tanya Nelson, PharmD; Mary Kremzner, PharmD; and Brenda J.

A Quick Guide to Understanding TE Codes

Kiliany, PharmD In the 1970s, state health agencies requested federal guidance relating to generic substitution of prescription drug products approved by the FDA. 1 This request resulted from the increase in new state statutes that allowed pharmacists to substitute lower-priced equivalent generic drug products for their branded counterparts.

Prior to the change in statutes, pharmacists were required to dispense only the exact drug product specified by the prescriber. If the physician prescribed a drug using the generic name, it became difficult for pharmacists to select a drug product that was therapeutically equivalent, because information was not available to determine which drug products were interchangeable. Few pharmacies were capable of stocking the same drug products manufactured by multiple companies. In response, the FDA prepared a list with therapeutic equivalence (TE) evaluations for FDA-approved drug products. ClinicalTrials.gov. A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study.An arm type in which a group of participants receives an intervention/treatment considered to be effective (or active) by health care providers.An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of time after the study has ended.

ClinicalTrials.gov

This change may or may not be caused by the intervention/treatment being studied.A type of eligibility criteria that indicates the age a person must be to participate in a clinical study. This may be indicated by a specific age or the following age groups:The age groups are: Child (birth-17)Adult (18-65)Senior (66+)A method used to assign participants to an arm of a clinical study. EU Clinical Trials Register. Int clinical trials portal. US drugs search. Drug categories description. Abortifacient Agents Chemical substances that interrupt pregnancy after implantation.

Drug categories description

Abortifacient Agents, Nonsteroidal Non-steroidal chemical compounds with abortifacient activity. Abortifacient Agents, Steroidal Steroidal compounds with abortifacient activity. Adhesives Substances that cause the adherence of two surfaces. Adjuvants, Anesthesia Agents that are administered in association with anesthetics to increase effectiveness, improve delivery, or decrease required dosage. Adjuvants, Immunologic Substances that augment, stimulate, activate, potentiate, or modulate the immune response at either the cellular or humoral level. Adjuvants, Pharmaceutic Agents that aid or increase the action of the principle drug (DRUG SYNERGISM) or that affect the absorption, mechanism of action, metabolism, or excretion of the primary drug (PHARMACOKINETICS) in such a way as to enhance its effects.

Adrenergic Agents Drugs that act on adrenergic receptors or affect the life cycle of adrenergic transmitters.