# GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
> **ANDA209692** · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL PHARMS · Approved 2018-11-01
## Drug
- **FDA Application Number:** ANDA209692
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
- **Generic name:** GUAIFENESIN, DEXTROMETHORPHAN HBR
- **Active ingredients:** DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- **Dosage form:** TABLET, EXTENDED RELEASE
- **Route:** ORAL
- **Marketing status:** Over-the-counter
- **Sponsor:** AMNEAL PHARMS
- **Manufacturer:** Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
- **First approval:** 2018-11-01
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209692)
---
*AI Analytics · CC0 1.0*