Viewing data from:

Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.

CIPRO XR

NDANot in Orange Book

CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE | N021554 | BAYER PHARMS

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

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 9, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 212.6MG; EQ 287.5MG BASE

▴

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

No patent or exclusivity listings for this strength.

#002 — 425.2MG; EQ 574.9MG BASE

▾

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