# NUCYNTA ER
> **NDA200533** · New Drug Application · Sponsor: COLLEGIUM PHARM INC · Approved 2011-08-25
## Drug
- **FDA Application Number:** NDA200533
- **Application type:** New Drug Application
- **Brand name:** NUCYNTA ER
- **Generic name:** TAPENTADOL HYDROCHLORIDE
- **Active ingredients:** TAPENTADOL HYDROCHLORIDE
- **Dosage form:** TABLET, EXTENDED RELEASE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** COLLEGIUM PHARM INC
- **Manufacturer:** Hikma Pharmaceuticals USA Inc.
- **First approval:** 2011-08-25
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=200533)
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