# FLUVOXAMINE MALEATE
> **ANDA220447** · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS · Approved 2026-07-21
## Drug
- **FDA Application Number:** ANDA220447
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** FLUVOXAMINE MALEATE
- **Generic name:** FLUVOXAMINE MALEATE EXTENDED-RELEASE
- **Active ingredients:** FLUVOXAMINE MALEATE
- **Dosage form:** CAPSULE, EXTENDED RELEASE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** ZYDUS PHARMS
- **Manufacturer:** Zydus Pharmaceuticals USA Inc.
- **First approval:** 2026-07-21
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220447)
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