# ROZEREM
> **NDA021782** · New Drug Application · Sponsor: TAKEDA PHARMS USA · Approved 2005-07-22
## Drug
- **FDA Application Number:** NDA021782
- **Application type:** New Drug Application
- **Brand name:** ROZEREM
- **Generic name:** RAMELTEON
- **Active ingredients:** RAMELTEON
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** TAKEDA PHARMS USA
- **Manufacturer:** Takeda Pharmaceuticals America, Inc.
- **First approval:** 2005-07-22
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021782)
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