# NERLYNX
> **NDA208051** · New Drug Application · Sponsor: PUMA BIOTECH · Approved 2017-07-17
## Drug
- **FDA Application Number:** NDA208051
- **Application type:** New Drug Application
- **Brand name:** NERLYNX
- **Generic name:** NERATINIB
- **Active ingredients:** NERATINIB MALEATE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** PUMA BIOTECH
- **Manufacturer:** Puma Biotechnology, Inc.
- **First approval:** 2017-07-17
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208051)
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