# ORKAMBI
> **NDA211358** · New Drug Application · Sponsor: VERTEX PHARMS INC · Approved 2018-08-07
## Drug
- **FDA Application Number:** NDA211358
- **Application type:** New Drug Application
- **Brand name:** ORKAMBI
- **Generic name:** LUMACAFTOR AND IVACAFTOR
- **Active ingredients:** IVACAFTOR; LUMACAFTOR
- **Dosage form:** GRANULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** VERTEX PHARMS INC
- **Manufacturer:** Vertex Pharmaceuticals Incorporated
- **First approval:** 2018-08-07
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211358)
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