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Tradename: SAMSCA

Summary for Tradename: SAMSCA

Patents:3
Applicants:1
NDAs:1
Suppliers: see list1
drug
patent expirations by year for
 SAMSCA

Clinical Trials for: SAMSCA

Post-Authorisation Safety Study of Samsca (Tolvaptan) Used in Routine Medical Practice
Status: Active, not recruiting Condition: SIADH; Non-SIADH Hyponatremia; Non-Hyponatremia

Bioavailability Study Comparing Tolvaptan Administered Via Nasogastric Tube to Tolvaptan Tablets Swallowed Intact
Status: Completed Condition: Healthy

Effects of Tolvaptan in Healthy Adults
Status: Recruiting Condition: Healthy

Effect of the Diuretic Tolvaptan on Nitric Oxide System. A Dose-response Study (DOVA)
Status: Recruiting Condition: Nephropathy

A PK Study of 3 Dosages of Tolvaptan in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
Status: Recruiting Condition: Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)

Randomized, Double-Blind, Placebo Controlled Study of the Short Term Clinical Effects of Tolvaptan in Patients Hospitalized for Worsening Heart Failure With Challenging Volume Management
Status: Recruiting Condition: Heart Failure

Phase III Study of Tolvaptan Tablet to Treat Cirrhosis Ascites
Status: Completed Condition: Ascites; Hepatic Cirrhosis

Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia
Status: Terminated Condition: Hyponatremia; Dilutional Hyponatremia; Inappropriate ADH Syndrome

Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia
Status: Not yet recruiting Condition: Hyponatremia

Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKD
Status: Completed Condition: Autosomal Dominant Polycystic Kidney Disease

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275May 19, 2009DISCNNo<disabled><disabled>
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275May 19, 2009DISCNNo5,258,510<disabled>YY<disabled>
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275May 19, 2009DISCNNo5,753,677<disabled><disabled>
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275May 19, 2009DISCNNo8,501,730<disabled>Y<disabled>
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Paragraph IV activity for: SAMSCA

Drugname Dosage Strength RLD Submissiondate
tolvaptanTablets15 mg and 30 mgSamsca9/23/2013

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