# KARBINAL ER
> **NDA022556** · New Drug Application · Sponsor: AYTU · Approved 2013-03-28
## Drug
- **FDA Application Number:** NDA022556
- **Application type:** New Drug Application
- **Brand name:** KARBINAL ER
- **Generic name:** CARBINOXAMINE MALEATE
- **Active ingredients:** CARBINOXAMINE MALEATE
- **Dosage form:** SUSPENSION, EXTENDED RELEASE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** AYTU
- **Manufacturer:** Neos Therapeutics, LP
- **First approval:** 2013-03-28
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022556)
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