# PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
> **ANDA091687** · Abbreviated New Drug Application (Generic) · Sponsor: COSETTE · Approved 2012-06-28
## Drug
- **FDA Application Number:** ANDA091687
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
- **Generic name:** PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
- **Active ingredients:** DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
- **Dosage form:** SYRUP
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** COSETTE
- **Manufacturer:** Cranbury Pharmaceuticals, LLC
- **First approval:** 2012-06-28
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=091687)
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