Hyponatremia
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FDA label_change · 2013-09-27FDA Approved: SAMSCA — Supplemental Application (Otsuka America Pharmaceutical, Inc.)
FDA supplemental application for SAMSCA (tolvaptan) submitted by Otsuka America Pharmaceutical, Inc., for a labeling change. The filing indi…
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FDA label_change · 2013-05-02FDA Approved: SAMSCA — Supplemental Application (Otsuka America Pharmaceutical, Inc.)
FDA supplemental application for SAMSCA (tolvaptan) from Otsuka America Pharmaceutical seeks labeling changes.
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FDA label_change · 2012-02-01FDA Approved: SAMSCA — Supplemental Application (Otsuka America Pharmaceutical, Inc.)
FDA approved a supplemental application for SAMSCA (tolvaptan) to update the labeling, including changes to indications or safety informatio…
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FDA label_change · 2011-09-23FDA Approved: SAMSCA — Supplemental Application (Otsuka America Pharmaceutical, Inc.)
FDA approved a supplemental application for SAMSCA (tolvaptan) submitted by Otsuka America Pharmaceutical, resulting in updated labeling for…