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 six 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. Nine 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:	6

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:	⤷ Sign Up	Patent Expiration:	Jul 17, 2026	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Sign Up	Patent Expiration:	Apr 15, 2024	Product Flag?		Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Jul 11, 2028	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	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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