# GATTEX KIT
> **NDA203441** · New Drug Application · Sponsor: TAKEDA PHARMS USA · Approved 2012-12-21
## Drug
- **FDA Application Number:** NDA203441
- **Application type:** New Drug Application
- **Brand name:** GATTEX KIT
- **Generic name:** TEDUGLUTIDE
- **Active ingredients:** TEDUGLUTIDE
- **Dosage form:** POWDER
- **Route:** SUBCUTANEOUS
- **Marketing status:** Prescription
- **Sponsor:** TAKEDA PHARMS USA
- **Manufacturer:** Takeda Pharmaceuticals America, Inc.
- **First approval:** 2012-12-21
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203441)
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