← FDA Drug Approvals (Drugs@FDA)
TOLVAPTAN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: APOTEX · Approved 2025-11-10
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
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