# ROFLUMILAST
> **ANDA208213** · Abbreviated New Drug Application (Generic) · Sponsor: HETERO LABS LTD III · Approved 2018-11-23
## Drug
- **FDA Application Number:** ANDA208213
- **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:** HETERO LABS LTD III
- **Manufacturer:** Camber Pharmaceuticals, Inc.
- **First approval:** 2018-11-23
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208213)
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