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Last Updated: November 12, 2024

Details for New Drug Application (NDA): 022275


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NDA 022275 describes SAMSCA, which is a drug marketed by Otsuka and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the SAMSCA profile page.

The generic ingredient in SAMSCA is tolvaptan. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the tolvaptan profile page.
Summary for 022275
Tradename:SAMSCA
Applicant:Otsuka
Ingredient:tolvaptan
Patents:2
Pharmacology for NDA: 022275
Suppliers and Packaging for NDA: 022275
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SAMSCA tolvaptan TABLET;ORAL 022275 NDA Otsuka America Pharmaceutical, Inc. 59148-020 59148-020-50 1 BLISTER PACK in 1 CARTON (59148-020-50) / 10 TABLET in 1 BLISTER PACK
SAMSCA tolvaptan TABLET;ORAL 022275 NDA Otsuka America Pharmaceutical, Inc. 59148-021 59148-021-50 1 BLISTER PACK in 1 CARTON (59148-021-50) / 10 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:May 19, 2009TE:ABRLD:Yes
Patent:⤷  Sign UpPatent Expiration:Apr 7, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Sep 1, 2026Product Flag?Substance Flag?YDelist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:May 19, 2009TE:ABRLD:Yes
Patent:⤷  Sign UpPatent Expiration:Apr 7, 2030Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 022275

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka SAMSCA tolvaptan TABLET;ORAL 022275-001 May 19, 2009 ⤷  Sign Up ⤷  Sign Up
Otsuka SAMSCA tolvaptan TABLET;ORAL 022275-003 May 19, 2009 ⤷  Sign Up ⤷  Sign Up
Otsuka SAMSCA tolvaptan TABLET;ORAL 022275-002 May 19, 2009 ⤷  Sign Up ⤷  Sign Up
Otsuka SAMSCA tolvaptan TABLET;ORAL 022275-001 May 19, 2009 ⤷  Sign Up ⤷  Sign Up
Otsuka SAMSCA tolvaptan TABLET;ORAL 022275-002 May 19, 2009 ⤷  Sign Up ⤷  Sign Up
Otsuka SAMSCA tolvaptan TABLET;ORAL 022275-003 May 19, 2009 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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