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CIPRO XR

NDA

CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE | N021473 | BAYER HEALTHCARE PHARMACEUTICALS INC

2 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Novel Probiotic-antibiotic Combination to Prevent Recurrent Urinary Tract Infections NCT06149676	Early Phase 1	Completed	Ann & Robert H Lurie Children's Hospital of Chicago	35	2022-02-02 → 2025-12-31

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

Approval Letters

26 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 212.6MG;EQ 287.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Dec 13, 2002

No patent or exclusivity listings for this strength.

#002 — 425.2MG;EQ 574.9MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Aug 28, 2003