# ROFLUMILAST
> **ANDA212490** · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2023-04-18
## Drug
- **FDA Application Number:** ANDA212490
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** ROFLUMILAST
- **Generic name:** ROFLUMILAST
- **Active ingredients:** ROFLUMILAST
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** ALKEM LABS LTD
- **Manufacturer:** Ascend Laboratories, LLC
- **First approval:** 2023-04-18
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212490)
---
*MORVS · CC0 1.0*