# IMKELDI
> **NDA219097** · New Drug Application · Sponsor: SHORLA ONCOLOGY · Approved 2024-11-22
## Drug
- **FDA Application Number:** NDA219097
- **Application type:** New Drug Application
- **Brand name:** IMKELDI
- **Generic name:** IMATINIB ORAL
- **Active ingredients:** IMATINIB MESYLATE
- **Dosage form:** SOLUTION
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** SHORLA ONCOLOGY
- **Manufacturer:** Shorla Oncology Inc.,
- **First approval:** 2024-11-22
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219097)
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*MORVS · CC0 1.0*