# PROMETHAZINE HYDROCHLORIDE
> **ANDA040428** · Abbreviated New Drug Application (Generic) · Sponsor: COSETTE · Approved 2002-02-05
## Drug
- **FDA Application Number:** ANDA040428
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** PROMETHAZINE HYDROCHLORIDE
- **Generic name:** PROMETHAZINE HYDROCHLORIDE
- **Active ingredients:** PROMETHAZINE HYDROCHLORIDE
- **Dosage form:** SUPPOSITORY
- **Route:** RECTAL
- **Marketing status:** Prescription
- **Sponsor:** COSETTE
- **Manufacturer:** Cosette Pharmaceuticals, Inc.
- **First approval:** 2002-02-05
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=040428)
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