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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. It is available from one supplier. There are fifteen patents protecting this drug. Additional details are available on the DEXILANT SOLUTAB profile page.

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

Summary for NDA: 208056

Tradename:
DEXILANT SOLUTAB
Applicant:
Takeda Pharms Usa
Ingredient:
dexlansoprazole
Patents:15

Pharmacology for NDA: 208056

Mechanism of ActionProton Pump Inhibitors

Suppliers and Packaging for NDA: 208056

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXILANT SOLUTAB
dexlansoprazole
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 208056 NDA Takeda Pharmaceuticals America, Inc. 64764-177 64764-177-01 1 BLISTER PACK in 1 CARTON (64764-177-01) > 5 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
DEXILANT SOLUTAB
dexlansoprazole
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 208056 NDA Takeda Pharmaceuticals America, Inc. 64764-177 64764-177-11 10 BLISTER PACK in 1 CARTON (64764-177-11) > 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORALStrength30MG
Approval Date:Jan 26, 2016TE:RLD:Yes
Patent:6,328,994*PEDPatent Expiration:Nov 17, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:6,462,058*PEDPatent Expiration:Dec 15, 2020Product Flag?Substance Flag?Delist Request?Y
Patent:6,664,276*PEDPatent Expiration:Jul 30, 2023Product Flag?Substance Flag?Delist Request?Y


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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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