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Details for New Drug Application (NDA): 022275

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

The generic ingredient in SAMSCA is tolvaptan. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tolvaptan profile page.

Summary for NDA: 022275

Tradename:
SAMSCA
Applicant:
Otsuka America Pharm
Ingredient:
tolvaptan
Patents:2
Formulation / Manufacturing:see details

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:May 19, 2009TE:RLD:No
Patent:8,501,730Patent Expiration:Sep 1, 2026Product Flag?Substance Flag?YDelist Request?
Patent:5,753,677Patent Expiration:May 19, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING HYPONATREMIA

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:May 19, 2009TE:RLD:Yes
Patent:8,501,730Patent Expiration:Sep 1, 2026Product Flag?Substance Flag?YDelist Request?

Expired Orange Book Patents for NDA: 022275

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275-001May 19, 20095,258,510► subscribe
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275-003May 19, 20095,258,510► subscribe
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275-002May 19, 20095,258,510► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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