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Last Updated: December 1, 2020

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Details for New Drug Application (NDA): 208056

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NDA 208056 describes DEXILANT SOLUTAB, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are eleven patents protecting this drug. Additional details are available on the DEXILANT SOLUTAB profile page.

The generic ingredient in DEXILANT SOLUTAB is dexlansoprazole. There are seventeen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dexlansoprazole profile page.

Summary for 208056

Tradename:	DEXILANT SOLUTAB
Applicant:	Takeda Pharms Usa
Ingredient:	dexlansoprazole
Patents:	11

Medical Subject Heading (MeSH) Categories for 208056

Anti-Ulcer Agents
Proton Pump Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL			Strength	30MG
Approval Date:	Jan 26, 2016	TE:		RLD:	Yes
Patent:	Start Trial	Patent Expiration:	Dec 15, 2020	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	Start Trial	Patent Expiration:	Jul 30, 2023	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	Start Trial	Patent Expiration:	Dec 15, 2020	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 208056

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016	Start Trial	Start Trial
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016	Start Trial	Start Trial
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016	Start Trial	Start Trial
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016	Start Trial	Start Trial
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016	Start Trial	Start Trial
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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