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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

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira
CIPROFLOXACIN
ciprofloxacin
INJECTABLE;INJECTION077245Aug 28, 2006RXNo<disabled><disabled>
Igi Labs Inc
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
SOLUTION/DROPS;OPHTHALMIC076754Jun 9, 2004RXNo<disabled><disabled>
Sandoz
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
TABLET;ORAL075939Mar 3, 2005DISCNNo<disabled><disabled>
Bayer Hlthcare
CIPRO
ciprofloxacin hydrochloride
TABLET;ORAL019537Apr 8, 1996RXNo<disabled><disabled>
Bayer Hlthcare
CIPRO XR
ciprofloxacin; ciprofloxacin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021473Dec 13, 2002DISCNNo7,709,022*PED<disabled>Y<disabled>
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ISSN: 2162-2639

Preferred citation:
Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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