# PALIPERIDONE PALMITATE
> **ANDA216674** · Abbreviated New Drug Application (Generic) · Sponsor: ACCORD HLTHCARE INC · Approved 2025-05-16
## Drug
- **FDA Application Number:** ANDA216674
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** PALIPERIDONE PALMITATE
- **Generic name:** Paliperidone Palmitate
- **Active ingredients:** PALIPERIDONE PALMITATE
- **Dosage form:** INJECTABLE
- **Route:** SUSPENSION, EXTENDED RELEASE
- **Marketing status:** None (Tentative Approval)
- **Sponsor:** ACCORD HLTHCARE INC
- **First approval:** 2025-05-16
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216674)
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