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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

Tradename:
PREVACID
Applicant:
Takeda Pharms Na
Ingredient:
lansoprazole
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SUSPENSION, DELAYED RELEASE;ORALStrength15MG/PACKET
Approval Date:May 3, 2001TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:FOR SUSPENSION, DELAYED RELEASE;ORALStrength30MG/PACKET
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
PREVACID
lansoprazole
FOR SUSPENSION, DELAYED RELEASE;ORAL021281-002May 3, 20014,689,333► subscribe
Takeda Pharms Na
PREVACID
lansoprazole
FOR SUSPENSION, DELAYED RELEASE;ORAL021281-001May 3, 20015,433,959*PED► subscribe
Takeda Pharms Na
PREVACID
lansoprazole
FOR SUSPENSION, DELAYED RELEASE;ORAL021281-001May 3, 20016,749,864► subscribe
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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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