Viewing data from:

PREVPAC (COPACKAGED)

NDA

AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE | N050757 | TAKEDA PHARMACEUTICALS USA INC

1 strength0 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 from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Haynes and Boone, LLP FDA-2018-P-3266 · 7 docket documents Haynes and Boone, LLP filed this citizen petition on behalf of VistaPharm Inc. requesting that the FDA withdraw its Draft Guidance for Mycophenolate Mofetil Oral Suspension and issue revised guidance requiring bioequivalence data for both the parent compound mycophenolate mofetil and its active meta	505(q)	2018-08-27	Partially Denied	Haynes and Boone, LLP

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

Clinical Trials

6 trials from ClinicalTrials.gov, 3 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Triple Therapy With Tegoprazan in H. Pylori Positive Patients NCT03498456	Phase 3	Completed	HK inno.N Corporation	284	2018-06-28 → 2019-12-31
The Effects of Helicobacter Pylori Eradication on Proteinuria in Patients With Membranous Nephropathy NCT00983034	N/A	Completed	Istanbul University	70	2006-03 → 2009-07
A Phase 3 Study to Evaluate the Efficacy and Safety of Triple Therapy With CJ-12420 in H. Pylori Positive Patients NCT03317223	Phase 3	Completed	HK inno.N Corporation	350	2017-10-17 → 2019-01-24
Tailored Treatment of H. Pylori Infection Based Polymorphisms of CYP2C19 and 23S rRNA of H. Pylori NCT00149084	Phase 3	UNKNOWN	Hamamatsu University	296	2003-04
First-line Antibiotic Therapy for Early-stage HP(+) Gastric Pure DLBCL NCT02388581	Phase 2	UNKNOWN	National Health Research Institutes, Taiwan	30	2014-12 → 2024-12
A Comparison of High-dose Dual Therapy and Half-dose Clarithromycin-containing Bismuth Quadruple Therapy for H.P Eradication in Elderly Patients NCT04101708	Phase 4	UNKNOWN	Shandong University	100	2019-09-20 → 2022-09-20

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

Approval Letters

19 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL | Approved: Dec 2, 1997

No patent or exclusivity listings for this strength.