# GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
> **ANDA214781** · Abbreviated New Drug Application (Generic) · Sponsor: SUN PHARM · Approved 2021-07-01
## Drug
- **FDA Application Number:** ANDA214781
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
- **Generic name:** GUAIFENESIN AND DEXTROMETHORPHAN HBR
- **Active ingredients:** DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- **Dosage form:** TABLET, EXTENDED RELEASE
- **Route:** ORAL
- **Marketing status:** Over-the-counter
- **Sponsor:** SUN PHARM
- **Manufacturer:** OHM LABORATORIES INC
- **First approval:** 2021-07-01
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214781)
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