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Profile for Tradename: CIPRO

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Cipro is a drug marketed by Bayer Hlthcare, Alcon Pharms Ltd, Bayer Pharms, Lupin Ltd, Bedford Labs, Claris Pharmaservice, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Teva Pharms Usa, Actavis Labs Fl Inc, Anchen Pharms, Dr Reddys Labs Ltd, Mylan Pharms Inc, Sandoz, Akorn Inc, Apotex Inc, Fdc Ltd, Igi Labs Inc, Nexus Pharms, Pharmaforce, Watson Labs Inc, Apotex, Aurobindo Pharma, Barr, Carlsbad, Hikma, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro, Teva, Unique Pharm Labs, Watson Labs, Acs Dobfar Info Sa, Baxter Hlthcare, Bedford, and Teva Pharms. and is included in fifty-five NDAs. It is available from one supplier. There are eight patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in CIPRO is ciprofloxacin; dexamethasone. There are thirty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.

Summary for Tradename: CIPRO

Suppliers / Packagers: see list4

Pharmacology for Tradename: CIPRO

Drug ClassQuinolone Antimicrobial

Clinical Trials for: CIPRO

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ivax Sub Teva Pharms
ciprofloxacin hydrochloride
TABLET;ORAL076089-002Jun 9, 2004RXNo<disabled><disabled>
ciprofloxacin hydrochloride
TABLET;ORAL076912-003Oct 6, 2004RXNo<disabled><disabled>
Dr Reddys Labs Ltd
ciprofloxacin; ciprofloxacin hydrochloride
TABLET, EXTENDED RELEASE;ORAL077701-002Oct 31, 2007DISCNNo<disabled><disabled>
Hikma Farmaceutica
INJECTABLE;INJECTION076717-002Dec 22, 2009RXNo<disabled><disabled>
ciprofloxacin hydrochloride
TABLET;ORAL076426-002Jun 15, 2005DISCNNo<disabled><disabled>
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Paragraph IV activity for: CIPRO

Drugname Dosage Strength RLD Submissiondate
ciprofloxacinOral Suspension250 mg/5 mL and 500 mg/ 5 mLCipro10/16/2009
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Preferred citation:

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

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