# BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
> **ANDA210647** · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2020-07-14
## Drug
- **FDA Application Number:** ANDA210647
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
- **Generic name:** BROMPHENIRAMINE, PSEUDOEPHEDRINE, DEXTROMETHORPHAN
- **Active ingredients:** BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
- **Dosage form:** SYRUP
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** ALKEM LABS LTD
- **Manufacturer:** Ascend Laboratories, LLC
- **First approval:** 2020-07-14
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210647)
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