Where can I find the detailed information and drug instructions of FDA-approved drugs?

The official information of new drugs, generic drugs and therapeutic biological products approved by FDA can be found in the drug database approved by FDA. The main purpose is to inquire about the label/instruction of drug approval number, seek the equivalent therapeutic products of innovative drugs and generic drugs, or find a generic drug of innovative drugs, check the drug approval history, and find all drugs corresponding to a specific active ingredient.

The "Drug Database Approved by FDA" contains the information of 40,000+drugs approved by FDA to be listed in the United States since 1939. You can inquire about the drug approval and registration information, drug instructions and related approval documents. Drug information mainly includes: trade name, applicant, application number, active ingredient, route of administration, reference preparation, reference drug for bioequivalence test, therapeutic equivalence code, drug submission type (new drug chemistry category), review category, approval history information, etc. The database is updated in real time, providing multi-dimensional retrieval, helping users to quickly query the latest approved drugs, the registration information of target products in the United States, drug instructions and other important information.

Fda-approved drugs

You can search for keywords by drug name, active ingredients, reporting enterprise, application number, first approval date, latest approval date, dosage form, route of administration, etc., you can also conduct conditional screening by application type, submission type, application route, market situation, China enterprise declaration, evaluation channel, orphan drug, first imitation drug, reference preparation, treatment equivalent code, etc., and you can also conduct fuzzy screening, accurate screening and combination.

For example, if you want to query the information of new drugs approved by FDA in the database, you can select "New Drug Application" in the application type to query the information of new drugs approved by FDA.

For example, click "Advanced Search" in the lower left corner, enter the drug name "Azithromycin", select "Harmony" and "Prescription Drugs", and filter the data of the famous Chinese medicine "Azithromycin" and the market state "Prescription Drugs" approved by FDA.

Fda-approved drug inquiry method

Search results are divided into approval data and global analysis.

The examination and approval data includes four browsing methods: query results, browsing by application number, browsing by effective components and browsing by bidding enterprises.

Click Global Analysis to enter the visual chart page, which contains the annual trend of drugs (total amount, new drugs, generic drugs, applications for biological products), submission type analysis, reporting enterprise T 10 analysis, active ingredient T 10 analysis and other visual data.

Global analysis of search results

Click "Drug Name" in the query results to enter the drug details page, which contains basic information of drugs, clinical trial results, drug specification information, NDC catalog information, initial approval information, supplementary application information, treatment equivalent information, patent information, market exclusive right protection information and drug-related information.