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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
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