Viewing data from:

CILOXAN

NDA

CIPROFLOXACIN HYDROCHLORIDE | N020369 | SANDOZ 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 JR Rapoza Associates, Inc. FDA-2007-P-0014 · 4 docket documents JRRapoza Associates, Inc. submitted this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA determination that Ciprofloxacin Hydrochloride Capsules in 100mg, 250mg, 500mg, and 750mg strengths are suitable for filing an Abbreviated New Drug Appli	Other	2008-04-11	Withdrawn	JR Rapoza Associates, Inc.

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

Clinical Trials

201 trials from ClinicalTrials.gov, 2 active, 145 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Regeneration of Immature Teeth. Case Series NCT03507556	N/A	Active	Jordan University of Science and Technology	40	2010-06-28 → 2030-12-01
CARNIVAL Study: Gut Flora Dependent Metabolism of Dietary CARNItine and Phosphatidylcholine and cardioVAscuLar Disease NCT01731236	Early Phase 1	Active	The Cleveland Clinic	100	2011-02-11 → 2029-12
Development of an Adjustment Assistance Tool Dosage of Fluoroquinolones in a Population Pharmacokinetic Model NCT02357407	Phase 4	Completed	Rennes University Hospital	31	2015-06 → 2016-12
Culture-guided Antimicrobial Prophylaxis in Men Undergoing Prostate Biopsy.NCT03228108	Phase 4	Completed	Radboud University Medical Center	1,538	2018-04-03 → 2021-09-26
Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)NCT01599806	Phase 3	Completed	Pfizer	641	2012-10 → 2014-08
Efficiency of Triple Antibiotic Paste, Ciprofloxacin/Propolis, Ciprofloxacin/Metronidazole, Propolis/Metronidazole Combinations on Revascularization Process of Immature Necrotic Maxillary Incisors of Patients 8-18 Years Old.NCT03533231	Phase 4	Completed	Tariq Yehia	40	2015-01-16 → 2018-01-01
Dose Ranging Study of OTO-201 in AOMT NCT02719158	Phase 2	Completed	Otonomy, Inc.	95	2016-02 → 2016-07
Bacterial Resistance in Patients Receiving Post-Intravitreal Injection Antibiotics NCT02223338	N/A	Completed	Loma Linda University	120	2014-10 → 2016-05
Short-course Methenamine Hippurate for Prevention of Post-operative UTI NCT02358993	N/A	Completed	University of Pennsylvania	201	2014-12 → 2020-09-30
Granulocyte-colony Stimulating Factors or Antibiotics for Primary Prophylaxis for Febrile Neutropenia NCT02816112	Phase 4	Completed	Ottawa Hospital Research Institute	458	2016-09 → 2020-04

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$74.35

per gm

Lowest NADAC/Unit

$74.35

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
66758007138CILOXAN 0.3% OINTMENT	$74.35	GM	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$171.90

Highest Price

$171.90

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
66758-0071-38CILOXAN 0.3% OINT,OPH	$171.90	FSS	Sandoz, Inc.	08/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain11 active DMFs13 inactive

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

BAYER AGCIPROFLOXACIN HYDROCHLORIDE

DMF 81341989

QUIMICA SINTETICA SACIPROFLOXACIN HYDROCHLORIDE

DMF 119661996

NEULAND LABORATORIES LTDCIPROFLOXACIN HYDROCHLORIDE USP

DMF 132501998

DR REDDYS LABORATORIES LTDCIPROFLOXACIN HYDROCHLORIDE, USP

DMF 138621998

HOLIDAY LABS MEXICO SA DE CVCIPROFLOXACIN HYDROCHLORIDE, USP

DMF 170612003

TARO PHARMACEUTICAL INDUSTRIES LTDCIPROFLOXACIN HYDROCHLORIDE, USP

DMF 179332004

ZHEJIANG HUAYI PHARMACEUTICAL CO LTDCIPROFLOXACIN HYDROCHLORIDE

DMF 180832004

AARTI DRUGS LTDCIPROFLOXACIN HYDROCHLORIDE

DMF 196112006

THINQ PHARMA-CRO LTDCIPROFLOXACIN HYDROCHLORIDE USP

DMF 306162016

TURTLE PHARMA PRIVATE LTDCIPROFLOXACIN HYDROCHLORIDE USP

DMF 332452018

PHLOW CORPCIPROFLOXACIN HYDROCHLORIDE USP

DMF 372062024

QUIMICA SINTETICA SAInactiveCIPROFLOXACIN HYDROCHLORIDE

DMF 85171990

CIPLA LTDInactiveCIPROFLOXACIN HYDROCHLORIDE USP IN BANGALORE, INDIA

DMF 86271990

UNION QUIMICO FARMACEUTICA SAInactiveCIPROFLOXACIN HYDROCHLORIDE

DMF 116021996

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveCIPROFLOXACIN HYDROCHLORIDE USP

DMF 130721998

CIPLA LTDInactiveCIPROFLOXACIN HYDROCHLORIDE USP

DMF 147092000

WOCKHARDT LTDInactiveCIPROFLOXACIN HYDROCHLORIDE, USP

DMF 149052000

MYLAN LABORATORIES LTDInactiveCIPROFLOXACIN HYDROCHLORIDE USP

DMF 165442003

UNIQUE CHEMICALSInactiveCIPROFLOXACIN HYDROCHLORIDE USP

DMF 177862004

APITORIA PHARMA PRIVATE LTDInactiveCIPROFLOXACIN HYDROCHLORIDE USP

DMF 185582005

ZHEJIANG XINHUA PHARMACEUTICAL CO LTDInactiveCIPROFLOXACIN HYDROCHLORIDE

DMF 198762006

ZHEJIANG JINGXIN PHARMACEUTICAL CO LTDInactiveCIPROFLOXACIN HYDROCHLORIDE

DMF 203372007

INDOCO REMEDIES LTDInactiveCIPROFLOXACIN HYDROCHLORIDE USP

DMF 219092008

SMRUTHI ORGANICS LTDInactiveCIPROFLOXACIN HYDROCHLORIDE USP

DMF 246362011

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Feb 21, 2017	SUPPL -22	View Letter (PDF)
Jul 21, 2004	SUPPL -9	View Letter (PDF)
Jul 21, 2004	SUPPL -10	View Letter (PDF)
Aug 28, 2003	SUPPL -6	View Letter (PDF)
Aug 28, 2003	SUPPL -7	View Letter (PDF)
Mar 30, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.3% BASE

RLD

0 patents0 exclusivities▴

OINTMENT;OPHTHALMIC | Approved: Mar 30, 1998

No patent or exclusivity listings for this strength.