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CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER

NDA

CIPROFLOXACIN | N019857 | 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

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain12 active DMFs4 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

BAYER AGCIPROFLOXACIN

DMF 89931991

BAYER AGCIPROFLOXACIN HYDRATED DRUG SUBSTANCE

DMF 103531993

DR REDDYS LABORATORIES LTDCIPROFLOXACIN HYDROCHLORIDE, USP

DMF 138621998

DR REDDYS LABORATORIES LTDCIPROFLOXACIN USP

DMF 146992000

QUIMICA SINTETICA SACIPROFLOXACIN

DMF 159132002

HOLIDAY LABS MEXICO SA DE CVCIPROFLOXACIN HYDROCHLORIDE, USP

DMF 170612003

HOLIDAY LABS MEXICO SA DE CVCIPROFLOXACIN

DMF 172792004

TARO PHARMACEUTICAL INDUSTRIES LTDCIPROFLOXACIN HYDROCHLORIDE, USP

DMF 179332004

NEULAND LABORATORIES LTDCIPROFLOXACIN USP

DMF 184652005

TURTLE PHARMA PRIVATE LTDCIPROFLOXACIN LACTATE

DMF 332472018

TURTLE PHARMA PRIVATE LTDCIPROFLOXACIN USP

DMF 332482018

ZHEJIANG GUOBANG PHARMACEUTICAL CO LTDCIPROFLOXACIN HCL 105 USP

DMF 342572019

BAYER CORP PHARMACEUTICAL DIVInactiveCIPROFLOXACIN OD

DMF 143171999

WOCKHARDT LTDInactiveCIPROFLOXACIN HYDROCHLORIDE, USP

DMF 149052000

MYLAN LABORATORIES LTDInactiveCIPROFLOXACIN USP

DMF 173052004

SMRUTHI ORGANICS LTDInactiveCIPROFLOXACIN USP

DMF 247752011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

29 letters from Drugs@FDA

Date	Submission	Document
May 11, 2020	SUPPL -72	View Letter (PDF)
May 7, 2019	SUPPL -69	View Letter (PDF)
Oct 23, 2018	SUPPL -68	View Letter (PDF)
Jul 28, 2017	SUPPL -66	View Letter (PDF)
Jul 26, 2016	SUPPL -65	View Letter (PDF)
Mar 20, 2015	SUPPL -64	View Letter (PDF)
Feb 12, 2015	SUPPL -63	View Letter (PDF)
Aug 16, 2013	SUPPL -62	View Letter (PDF)
Jan 31, 2013	SUPPL -60	View Letter (PDF)
Nov 21, 2011	SUPPL -53	View Letter (PDF)
Oct 20, 2011	SUPPL -59	View Letter (PDF)
Aug 15, 2011	SUPPL -57	View Letter (PDF)
Aug 8, 2011	SUPPL -58	View Letter (PDF)
Mar 2, 2011	SUPPL -54	View Letter (PDF)
Jun 30, 2009	SUPPL -52	View Letter (PDF)
May 7, 2009	SUPPL -51	View Letter (PDF)
Feb 18, 2009	SUPPL -50	View Letter (PDF)
Jan 24, 2008	SUPPL -48	View Letter (PDF)
Jul 5, 2007	SUPPL -46	View Letter (PDF)
Jun 28, 2006	SUPPL -42	View Letter (PDF)
Nov 18, 2005	SUPPL -41	View Letter (PDF)
May 20, 2005	SUPPL -38	View Letter (PDF)
Jan 11, 2005	SUPPL -35	View Letter (PDF)
Jul 21, 2004	SUPPL -34	View Letter (PDF)
Jul 21, 2004	SUPPL -33	View Letter (PDF)
Jul 21, 2004	SUPPL -36	View Letter (PDF)
Mar 28, 2004	SUPPL -31	View Letter (PDF)
Apr 17, 2002	SUPPL -28	View Letter (PDF)
Aug 30, 2000	SUPPL -27	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Dec 26, 1990

No patent or exclusivity listings for this strength.

#002 — 400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Dec 26, 1990