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

Mechanism of Action	Vasopressin V2 Receptor Antagonists

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:	RX	Dosage:	TABLET;ORAL			Strength	15MG
Approval Date:	May 19, 2009	TE:	AB	RLD:	Yes
Patent:	⤷ Subscribe	Patent Expiration:	Apr 7, 2030	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Subscribe	Patent Expiration:	Sep 1, 2026	Product Flag?		Substance Flag?	Y	Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	30MG
Approval Date:	May 19, 2009	TE:	AB	RLD:	Yes
Patent:	⤷ Subscribe	Patent Expiration:	Apr 7, 2030	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 022275

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

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