# TOLVAPTAN
> **ANDA218381** · Abbreviated New Drug Application (Generic) · Sponsor: APOTEX · Approved 2025-11-10
## Drug
- **FDA Application Number:** ANDA218381
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** TOLVAPTAN
- **Generic name:** Tolvaptan
- **Active ingredients:** TOLVAPTAN
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** APOTEX
- **First approval:** 2025-11-10
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218381)
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*MORVS · CC0 1.0*