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Details for New Drug Application (NDA): 021428

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NDA 021428 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: 021428

Tradename:
PREVACID
Applicant:
Takeda Pharms Usa
Ingredient:
lansoprazole
Patents:4
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021428

Mechanism of ActionProton Pump Inhibitors
Physiological EffectInhibition Gastric Acid Secretion

Suppliers and Packaging for NDA: 021428

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREVACID
lansoprazole
TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL 021428 NDA Rebel Distributors Corp 21695-106 21695-106-15 15 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BOTTLE (21695-106-15)
PREVACID
lansoprazole
TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL 021428 NDA Physicians Total Care, Inc. 54868-5303 54868-5303-0 30 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BOTTLE (54868-5303-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORALStrength15MG
Approval Date:Aug 30, 2002TE:RLD:No
Patent:6,328,994*PEDPatent Expiration:Nov 17, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:7,399,485*PEDPatent Expiration:Nov 26, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:7,431,942*PEDPatent Expiration:Nov 17, 2019Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021428

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa
PREVACID
lansoprazole
TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL021428-001Aug 30, 20024,628,098*PED► subscribe
Takeda Pharms Usa
PREVACID
lansoprazole
TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL021428-002Aug 30, 20024,628,098*PED► subscribe
Takeda Pharms Usa
PREVACID
lansoprazole
TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL021428-001Aug 30, 20025,045,321*PED► 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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