# PROMETHAZINE PLAIN
> **ANDA087953** · Abbreviated New Drug Application (Generic) · Sponsor: PHARMOBEDIENT · Approved 1982-11-15
## Drug
- **FDA Application Number:** ANDA087953
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** PROMETHAZINE PLAIN
- **Generic name:** PROMETHAZINE HYDROCHLORIDE
- **Active ingredients:** PROMETHAZINE HYDROCHLORIDE
- **Dosage form:** SYRUP
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** PHARMOBEDIENT
- **Manufacturer:** Xttrium Laboratories, Inc.
- **First approval:** 1982-11-15
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=087953)
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