# SYMDEKO (COPACKAGED)
> **NDA210491** · New Drug Application · Sponsor: VERTEX PHARMS INC · Approved 2018-02-12
## Drug
- **FDA Application Number:** NDA210491
- **Application type:** New Drug Application
- **Brand name:** SYMDEKO (COPACKAGED)
- **Generic name:** TEZACAFTOR AND IVACAFTOR
- **Active ingredients:** IVACAFTOR; IVACAFTOR, TEZACAFTOR
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** VERTEX PHARMS INC
- **Manufacturer:** Vertex Pharmaceuticals Incorporated
- **First approval:** 2018-02-12
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210491)
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