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PREVACID NAPRAPAC 250 (COPACKAGED)

NDA

LANSOPRAZOLE; NAPROXEN | N021507 | TAKEDA PHARMACEUTICALS NORTH AMERICA INC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Lachman Consultant Services, Inc. FDA-2006-P-0004 · 6 docket documents Lachman Consultant Services, Inc. filed this petition requesting that the FDA determine whether Tap Pharm's Prevacid NapraPACT 15 mg/250 mg (lansoprazole delayed-release and naproxen kit, NDA No. 021507) was voluntarily withdrawn from sale for reasons of safety or effectiveness, as the lower strengt	Other	2008-08-11	Open	Lachman Consultant Services, Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Comparison of Safety and Treatment in Subjects With Osteoarthritis Taking Low Dose Aspirin NCT00175032	Phase 3	Completed	Takeda	1,045	2003-07 → 2004-07

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Approval Letters

4 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (3)

Sort:

#002 — 15MG,N/A;N/A,250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CAPSULE, DELAYED REL PELLETS, TABLET;ORAL | Approved: Nov 14, 2003

No patent or exclusivity listings for this strength.

#003 — 15MG,N/A;N/A,375MG

0 patents0 exclusivities▾

CAPSULE, DELAYED REL PELLETS, TABLET;ORAL | Approved: Nov 14, 2003

#004 — 15MG,N/A;N/A,500MG

0 patents0 exclusivities▾

CAPSULE, DELAYED REL PELLETS, TABLET;ORAL | Approved: Nov 14, 2003