# PROMETHAZINE HYDROCHLORIDE
> **ANDA040643** · Abbreviated New Drug Application (Generic) · Sponsor: PHARM ASSOC · Approved 2006-04-26
## Drug
- **FDA Application Number:** ANDA040643
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** PROMETHAZINE HYDROCHLORIDE
- **Generic name:** PROMETHAZINE HYDROCHLORIDE
- **Active ingredients:** PROMETHAZINE HYDROCHLORIDE
- **Dosage form:** SYRUP
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** PHARM ASSOC
- **Manufacturer:** PAI Holdings, LLC dba PAI Pharma
- **First approval:** 2006-04-26
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=040643)
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