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Details for Generic Name: ciprofloxacin

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Ciprofloxacin is the generic ingredient in fourteen branded drugs marketed by Bayer Hlthcare, Lupin Ltd, Bayer Pharms, Bedford Labs, Claris Lifesciences, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Teva Pharms Usa, Acs Dobfar Info Sa, Baxter Hlthcare, Bedford, Teva Pharms, Alcon Pharms Ltd, Akorn Inc, Apotex Inc, Fdc Ltd, Igi Labs Inc, Nexus Pharms, Pharmaforce, Watson Labs Inc, Wraser Pharms, Depomed Inc, Apotex, Aurobindo Pharma, Barr, Carlsbad, Dr Reddys Labs Ltd, Hikma, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Ranbaxy, Sandoz, Taro, Teva, Unique Pharm Labs, Watson Labs, Actavis Labs Fl Inc, Anchen Pharms, and Mylan Pharms Inc, and is included in fifty-nine NDAs. There are thirteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are thirty drug master file entries for ciprofloxacin. One supplier is listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: ciprofloxacin

Tradenames:14
Patents:13
Applicants:42
NDAs:59
Drug Master File Entries: see list30
Suppliers: see list1
Therapeutic Class:Antibacterials

Pharmacology for Ingredient: ciprofloxacin

Ingredient-typeQuinolones
Drug ClassQuinolone Antimicrobial

Tentative approvals for CIPROFLOXACIN

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL100MG
<disabled><disabled>Tablet; Oral100MG

Clinical Trials for: ciprofloxacin

Study to Evaluate the Safety and Efficacy of Ciprofloxacin (Inhaled) in Patients With Cystic Fibrosis
Status: Completed Condition: Cystic Fibrosis

Evaluation of Cipro Inhale in Patients With Non-cystic Fibrosis Bronchiectasis
Status: Completed Condition: Bronchiectasis

Impact of Formulation on Ciprofloxacin Oral Absorption
Status: Completed Condition: Healthy

Drug - Drug Interaction Study of Quinine Sulfate and Ciprofloxacin
Status: Completed Condition: Healthy

Ciprofloxacin XR Drug Interaction Study With MMX® Mesalazine/Mesalamine
Status: Completed Condition: Healthy

Ciprofloxacin for Prevention of BK Infection
Status: Recruiting Condition: BK Virus Infection

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Taro
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
TABLET;ORAL076912Feb 18, 2005RXNo<disabled><disabled>
Acs Dobfar Info Sa
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ciprofloxacin
INJECTABLE;INJECTION078252Mar 18, 2008RXNo<disabled><disabled>
Wraser Pharms
CETRAXAL
ciprofloxacin hydrochloride
SOLUTION/DROPS;OTIC021918May 1, 2009RXYes<disabled><disabled>
Actavis Labs Fl Inc
CIPROFLOXACIN EXTENDED RELEASE
ciprofloxacin; ciprofloxacin hydrochloride
TABLET, EXTENDED RELEASE;ORAL077417Nov 30, 2010RXNo<disabled><disabled>
Bayer Hlthcare
CIPRO
ciprofloxacin hydrochloride
TABLET;ORAL019537Oct 22, 1987RXNo<disabled><disabled>
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