# PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE
> **ANDA200963** · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL PHARMS · Approved 2015-08-26
## Drug
- **FDA Application Number:** ANDA200963
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE
- **Generic name:** PROMETHAZINE, PHENYLEPHRINE, CODEINE
- **Active ingredients:** CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
- **Dosage form:** SYRUP
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** AMNEAL PHARMS
- **Manufacturer:** Amneal Pharmaceuticals LLC
- **First approval:** 2015-08-26
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=200963)
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