← FDA Drug Approvals (Drugs@FDA)
SAMSCA
NDA · New Drug Application · Sponsor: OTSUKA · Approved 2009-05-19
Drug application
- FDA Application #
NDA022275
- Application type
- New Drug Application
- Brand name
- SAMSCA
- Generic name
- TOLVAPTAN
- Active ingredients
- TOLVAPTAN
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- OTSUKA
- Manufacturer
- Otsuka America Pharmaceutical, Inc.
- First approval
- 2009-05-19
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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