# GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
> **ANDA212542** · Abbreviated New Drug Application (Generic) · Sponsor: SUN PHARM INDS INC · Approved 2020-04-28
## Drug
- **FDA Application Number:** ANDA212542
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
- **Generic name:** GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
- **Active ingredients:** GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
- **Dosage form:** TABLET, EXTENDED RELEASE
- **Route:** ORAL
- **Marketing status:** Over-the-counter
- **Sponsor:** SUN PHARM INDS INC
- **Manufacturer:** RUGBY LABORATORIES, INC.
- **First approval:** 2020-04-28
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212542)
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