# CARBAMAZEPINE
> **ANDA216594** · Abbreviated New Drug Application (Generic) · Sponsor: UMEDICA · Approved 2022-08-18
## Drug
- **FDA Application Number:** ANDA216594
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** CARBAMAZEPINE
- **Generic name:** CARBAMAZEPINE
- **Active ingredients:** CARBAMAZEPINE
- **Dosage form:** TABLET, EXTENDED RELEASE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** UMEDICA
- **Manufacturer:** Northstar Rx LLC
- **First approval:** 2022-08-18
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216594)
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