# ROFLUMILAST
> **ANDA208303** · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS · Approved 2022-02-10
## Drug
- **FDA Application Number:** ANDA208303
- **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:** ZYDUS PHARMS
- **Manufacturer:** Zydus Pharmaceuticals USA Inc.
- **First approval:** 2022-02-10
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208303)
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