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Details for New Drug Application (NDA): 021281

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NDA 021281 describes PREVACID, which is a drug marketed by Takeda Pharms Usa, Takeda Pharms Na, and Glaxosmithkline Cons, and is included in six NDAs. It is available from nine suppliers. There are five patents protecting this drug and two Paragraph IV challenges. Additional details are available on the PREVACID profile page.

The generic ingredient in PREVACID is lansoprazole; naproxen. There are fifty-four drug master file entries for this compound. Additional details are available on the lansoprazole; naproxen profile page.

Summary for NDA: 021281

Takeda Pharms Na
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Summary for product number 001

Approval Date:May 3, 2001TE:RLD:No

Summary for product number 002

Approval Date:May 3, 2001TE:RLD:No

Expired Orange Book Patents for NDA: 021281

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Na
FOR SUSPENSION, DELAYED RELEASE;ORAL021281-002May 3, 20014,689,333► subscribe
Takeda Pharms Na
FOR SUSPENSION, DELAYED RELEASE;ORAL021281-001May 3, 20015,433,959*PED► subscribe
Takeda Pharms Na
FOR SUSPENSION, DELAYED RELEASE;ORAL021281-001May 3, 20016,749,864► subscribe
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