# PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
> **ANDA218264** · Abbreviated New Drug Application (Generic) · Sponsor: HETERO LABS LTD III · Approved 2026-03-12
## Drug
- **FDA Application Number:** ANDA218264
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
- **Generic name:** Dextromethorphan Hydrobromide
- **Active ingredients:** DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
- **Dosage form:** SYRUP
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** HETERO LABS LTD III
- **First approval:** 2026-03-12
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218264)
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