# IVACAFTOR
> **ANDA216074** · Abbreviated New Drug Application (Generic) · Sponsor: LUPIN LTD · Approved 2022-06-07
## Drug
- **FDA Application Number:** ANDA216074
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** IVACAFTOR
- **Generic name:** Ivacaftor
- **Active ingredients:** IVACAFTOR
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** None (Tentative Approval)
- **Sponsor:** LUPIN LTD
- **First approval:** 2022-06-07
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216074)
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