Approved drugs (FDA)
Every NDA, ANDA and BLA in Drugs@FDA and the Purple Book, with Orange Book patents and exclusivities, prescription labels and NDC products. Newest first approval first.
Company Applications whose Drugs@FDA sponsor matches PUMA BIOTECHNOLOGY, INC. Remove the company filter
Results
1 application, newest first approval first
| Application | Brand names | Active ingredients | Sponsor | First approved | Latest action | Status | FDA record |
|---|---|---|---|---|---|---|---|
| NDA 2080511 product | NERLYNX | NERATINIB MALEATE | PUMA BIOTECHPBYI | Prescription | Drugs@FDA record for NDA208051 (opens in a new tab) |
Data provided by the U.S. Food and Drug Administration. Showing it here is not an FDA endorsement. Sources: Drugs@FDA, the Orange Book and the Purple Book (public domain). A sponsor links to a company only when its name matches one company. Nothing here is investment advice.