# PROMETHAZINE HYDROCHLORIDE
> **ANDA084176** · Abbreviated New Drug Application (Generic) · Sponsor: SANDOZ · Approved 1975-02-18
## Drug
- **FDA Application Number:** ANDA084176
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** PROMETHAZINE HYDROCHLORIDE
- **Generic name:** Promethazine Hydrochloride
- **Active ingredients:** PROMETHAZINE HYDROCHLORIDE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** SANDOZ
- **First approval:** 1975-02-18
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=084176)
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