# KALYDECO
> **NDA203188** · New Drug Application · Sponsor: VERTEX PHARMS · Approved 2012-01-31
## Drug
- **FDA Application Number:** NDA203188
- **Application type:** New Drug Application
- **Brand name:** KALYDECO
- **Generic name:** IVACAFTOR
- **Active ingredients:** IVACAFTOR
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** VERTEX PHARMS
- **Manufacturer:** Vertex Pharmaceuticals Incorporated
- **First approval:** 2012-01-31
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203188)
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