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Details for New Drug Application (NDA): 021566

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NDA 021566 describes PREVACID IV, which is a drug marketed by Takeda Pharms Na and is included in one NDA. There is one patent protecting this drug. Additional details are available on the PREVACID IV profile page.

The generic ingredient in PREVACID IV is lansoprazole. There are fifty-four drug master file entries for this compound. Eighty-three suppliers are listed for this compound. Additional details are available on the lansoprazole profile page.

Summary for NDA: 021566

Takeda Pharms Na
Therapeutic Class:Gastrointestinal Agents

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAVENOUSStrength30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:May 27, 2004TE:RLD:No
Patent:7,396,841*PEDPatent Expiration:Feb 17, 2022Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021566

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Na
INJECTABLE;INTRAVENOUS021566-001May 27, 20044,628,098*PED► subscribe
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