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Details for New Drug Application (NDA): 022287

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NDA 022287 describes DEXILANT, which is a drug marketed by Takeda Pharms Usa and is included in two NDAs. It is available from three suppliers. There are twenty-one patents protecting this drug and two Paragraph IV challenges. Additional details are available on the DEXILANT profile page.

The generic ingredient in DEXILANT 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: 022287

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

Pharmacology for NDA: 022287

Mechanism of ActionProton Pump Inhibitors

Suppliers and Packaging for NDA: 022287

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXILANT
dexlansoprazole
CAPSULE, DELAYED RELEASE;ORAL 022287 NDA Physicians Total Care, Inc. 54868-5998 54868-5998-0 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (54868-5998-0)
DEXILANT
dexlansoprazole
CAPSULE, DELAYED RELEASE;ORAL 022287 NDA Physicians Total Care, Inc. 54868-5998 54868-5998-1 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (54868-5998-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength30MG
Approval Date:Jan 30, 2009TE:RLD:No
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
Patent:6,939,971*PEDPatent Expiration:Dec 15, 2020Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 022287

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa
DEXILANT
dexlansoprazole
CAPSULE, DELAYED RELEASE;ORAL022287-001Jan 30, 20095,045,321*PED► subscribe
Takeda Pharms Usa
DEXILANT
dexlansoprazole
CAPSULE, DELAYED RELEASE;ORAL022287-002Jan 30, 20095,433,959*PED► subscribe
Takeda Pharms Usa
DEXILANT
dexlansoprazole
CAPSULE, DELAYED RELEASE;ORAL022287-002Jan 30, 20095,045,321*PED► subscribe
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