FDA drug approvals

What FDA approval data is

The FDA's approval records describe which drug products have been authorised for marketing in the United States. The authoritative datasets are Drugs@FDA — which holds application numbers, sponsors (the companies that hold the applications), products, product forms and marketing status — and the Orange Book, which lists approved products with therapeutic-equivalence evaluations and patent and exclusivity information. Together these are the canonical public reference for what has been approved, by whom, and in what form.

For regulatory-affairs, competitive-intelligence and procurement teams, approval data answers a different question from recalls and shortages: not "what went wrong or ran short," but "what is authorised to be on the market." A new approval changes what a company can legally market; a change in marketing status can signal a product entering or leaving the market. Indexed well, this layer complements the recall and shortage views to give a fuller picture of a product's or a firm's regulatory footprint.

Current status on this site: active

The approvals layer currently has indexed records, drawn from the openFDA Drugs@FDA dataset. The most recent application records are listed below. Each value is reproduced as a regulatory data field; this page makes no claim about the clinical role of any product and offers no medical advice.

Where to get authoritative approval data now

Until this layer is fully populated, the authoritative public sources are available directly from the FDA. Drugs@FDA can be searched at the official portal, and the Orange Book data files are published by the agency for bulk download. The FDA data sources page lists these with their official URLs, a description of what each contains, and their known limitations. For the terminology used here — application number, sponsor, marketing status — see the regulatory intelligence glossary.

This conservative approach is deliberate and is part of the site's data-quality policy: we would rather under-promise and link you to the regulator's authoritative record than present an approvals list we cannot stand behind. The same principle governs every dataset on the site.

How an approvals layer would cross-link with the rest of the site

When the approvals layer is populated, it is designed to slot into the same manufacturer-centric structure as recalls and shortages. Each approval record names a sponsor — the company that holds the application — and that sponsor is normalised into the same firm identity used elsewhere on the site. The effect is that a single manufacturer page can bring together a firm's recall records, its shortage records and its approvals into one regulatory footprint, all as coverage-limited activity signals rather than as any kind of rating. Application numbers tie each approval to the FDA's own systems, product-form and marketing-status fields are carried as descriptive data points, and every record links back to the verifiable source.

Until that source is wired in, the approvals layer stays deferred and this page says so plainly. This is the same data-quality discipline applied across the site: index only what can be traced to an official source, never fabricate, and prefer linking you to the regulator's authoritative record over presenting a dataset that cannot be stood behind. The recalls and shortages layers, which have dependable openFDA APIs, are fully populated and carry the site in the meantime.