Orange Book · Purple Book · DMF · Shortages
Every approved drug.Every licensed biologic.
Four FDA archives, searchable — with the patents, exclusivities, biosimilars, master files and supply alerts attached to each record.
Orange Book
Approved drug products with therapeutic equivalence evaluations.
- Search the archive by ingredient, brand name or applicant
- Filter and sort the whole archive in a full-screen table
- A page per active ingredient, with its applications, patents and exclusivities
Purple Book
Licensed biological products, their biosimilars, and when their exclusivity ends.
- Browse licensed biologics as a grid or a table
- See which licences are biosimilar, and which are interchangeable
- A page per licence and per biologic substance
Drug Master Files
The FDA’s quarterly list of DMFs — who filed, what for, and whether it is still active.
- Search 41,000 filings by DMF number, holder or subject
- Filter by type and status, with the type spelled out in full
- Sorted numerically, so page one opens on 0, 1, 2 — not 0, 1, 10, 100
Drug Shortages
Every drug the FDA currently lists as in short supply, and why.
- Search by drug, company or package NDC
- Filter by status, availability and dosage form
- The reason behind each shortage, and the packaging it affects
National Drug Code Directory
Every drug product listed with the FDA under an NDC, and the packages it ships in.
- Search by drug, labeler, NDC or application number
- Filter by dosage form, route, marketing category, type and DEA schedule
- A page per NDC, with its package listings and pharmacologic class
Drug Labels
Structured Product Labeling — the prescribing information and Drug Facts panels that ship with a marketed drug.
- Search 262,000 labels by title or labeler
- Narrow to the labels that carry a particular section, such as a boxed warning
- A page per SPL lineage, with every landed section
Drugs@FDA Applications
Every drug application the FDA has acted on — NDAs, their generic equivalents and biologics licences.
- Search by application number or sponsor company
- Filter by type, status and submission class
- A page per application, with its full submission and review-document history
Drug Enforcement
FDA drug recalls and enforcement reports.
- Search by recall number, firm, or product description
- Filter by classification, status, and product type
- A page per enforcement report
Cosmetic Adverse Events
Reports of reactions to cosmetic products, collected by the FDA under MoCRA.
- Search by report number or implicated product name
- Filter by report type and reported gender
- A page per report, with its reactions, outcomes and products