FDA maintains several public databases for different record types. Checking status begins by identifying the exact product and choosing the database that covers that kind of record. PeptideHQ does not search for a product, interpret a result, or make a legal or medical determination.

What an approval record means

In this guide, “FDA approved” refers narrowly to an FDA approval in force for a particular product and application. The record and its labeling identify the product, applicant, strength, dosage form, route, and approved uses covered by that action. It is not blanket approval of a substance, every formulation, every use, or every product bearing a similar name.

FDA's approved-drug resources explain the scope of the principal databases. Read the actual application record and labeling rather than relying on a general claim that something is “FDA approved.”

Choose the database that matches the record

Begin with Drugs@FDA

Open Drugs@FDA and use the exact proprietary or nonproprietary name when available. Compare the application number, applicant, approval history, letters, and label date. FDA says the database contains most approved drug products since 1939 and much of the supporting material for approvals since 1998.

Use the Orange Book when relevant

The Orange Book covers approved drug products under the Federal Food, Drug, and Cosmetic Act, with therapeutic-equivalence evaluations for certain multisource prescription products and related patent and exclusivity information.

Use the Purple Book for biologics

The Purple Book covers FDA-licensed biological products, including biosimilar and interchangeable products and their reference products. Record the BLA number and the specific product entry.

The FDA Drug Approvals and Databases directory links to each official resource. The About Drugs@FDA page, Orange Book page, and Purple Book Search describe their current coverage.

Keep registration, listing, marketing, and research separate

An entry in the NDC Directory does not, by itself, establish FDA approval. FDA states that inclusion does not indicate that FDA verified the submitted information or approved the product, and assignment of an NDC number does not denote approval.

Establishment registration, inspection, and product listing are also different from approval of a particular product application. FDA's consumer explanation of what it does and does not approve says that mere registration or listing does not denote approval and does not establish that a product may be lawfully marketed.

A ClinicalTrials.gov record shows that study information was registered. The ClinicalTrials.gov disclaimer explains that registration is not government approval of a study's safety or science. A registry record is not proof that a product is approved, safe, or effective.

Match the record to the exact product

Do not generalize an approval across a different product, formulation, route, indication, strength, or manufacturer. Compare the name, application holder, application number, product number when present, labeling, approval history, and dates. A shared ingredient name or similar marketing description is not enough to establish that two products have the same regulatory status.

Do not turn a missing result into a final conclusion

Absence from one database can reflect that database's scope, a spelling or naming difference, an older record, a different FDA center, or another record type. PeptideHQ does not convert a missing result into a definitive conclusion about legality, approval, medical suitability, or authenticity. Check the database's coverage, try documented names or identifiers, and record exactly what was searched and when.

Record what you checked

Copy these headings into your own notes. Preserve the exact wording shown by the official database without adding a conclusion that the record does not state.

Static record-check worksheet

A plain-text observation log for manual use.

Database checked:
Search term:
Application number:
Record status:
Label date:
Date checked:
Exact record URL:
Notes limited to what the record states:

This worksheet does not accept, submit, calculate, save, interpret, or personalize information.

Keep personal treatment questions separate

An approval record does not answer whether a product is appropriate for a particular person. Personal treatment questions require an appropriately qualified healthcare professional who can consider the relevant circumstances and current official labeling.

Source record

Authoritative sources

  1. U.S. Food and Drug Administration Drug Approvals and Databases FDA's directory of Drugs@FDA, the Orange Book, the Purple Book, the NDC Directory, and other records.
  2. U.S. Food and Drug Administration Drugs@FDA Search Official product, application, labeling, approval-history, and review records.
  3. U.S. Food and Drug Administration About Drugs@FDA Official scope, coverage dates, and update information for Drugs@FDA.
  4. U.S. Food and Drug Administration Resources for Information: Approved Drugs Official distinctions among Drugs@FDA, the Orange Book, and the Purple Book.
  5. U.S. Food and Drug Administration Orange Book Approved drug products, therapeutic-equivalence evaluations, and related patent and exclusivity information.
  6. U.S. Food and Drug Administration Purple Book Search FDA-licensed biological products, including biosimilar and interchangeable products and their reference products.
  7. U.S. Food and Drug Administration National Drug Code Directory FDA's explanation that directory inclusion and NDC assignment do not denote approval.
  8. U.S. Food and Drug Administration Is It Really 'FDA Approved'? Official distinctions among product approval, establishment registration, inspection, and product listing.
  9. ClinicalTrials.gov ClinicalTrials.gov Disclaimer Official limits on what study registration establishes.