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Ciprofloxacin hydrochlorideis the generic ingredient in seven branded drugs marketed by Novartis, Akorn, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Rising, Rubicon, Teligent, Watson Labs Inc, Wraser Pharms, Depomed Inc, Bayer Hlthcare, Ani Pharms Inc, Aurobindo Pharma, Barr, Carlsbad, Chartwell, Dr Reddys Labs Ltd, Fosun Pharma, Hikma, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro, Teva, Unique Pharm Labs, Watson Labs, Yiling, and Laboratorios Salvat, and is included in thirty-four NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.
There are thirty-four drug master file entries for ciprofloxacin hydrochloride. Fifty-seven suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for CIPROFLOXACIN HYDROCHLORIDE
|Drug Master File Entries:||34|
|Finished Product Suppliers / Packagers:||57|
|Raw Ingredient (Bulk) Api Vendors:||83|
|Formulation / Manufacturing:||see details|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for CIPROFLOXACIN HYDROCHLORIDE|
|What excipients (inactive ingredients) are in CIPROFLOXACIN HYDROCHLORIDE?||CIPROFLOXACIN HYDROCHLORIDE excipients list|
|DailyMed Link:||CIPROFLOXACIN HYDROCHLORIDE at DailyMed|
Recent Clinical Trials for CIPROFLOXACIN HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
|National Institute for Health Research, United Kingdom||N/A|
|University College, London||N/A|
|University of Alberta||Phase 2|
Generic filers with tentative approvals for CIPROFLOXACIN HYDROCHLORIDE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for CIPROFLOXACIN HYDROCHLORIDE
|Drug Class||Quinolone Antimicrobial |
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Patent No.||Patent Expiration|
|Bayer Hlthcare||CIPRO||ciprofloxacin hydrochloride||TABLET;ORAL||019537-001||Apr 8, 1996||Get Started for $10||Get Started for $10|
|Depomed Inc||PROQUIN XR||ciprofloxacin hydrochloride||TABLET, EXTENDED RELEASE;ORAL||021744-001||May 19, 2005||Get Started for $10||Get Started for $10|
|Novartis||CILOXAN||ciprofloxacin hydrochloride||OINTMENT;OPHTHALMIC||020369-001||Mar 30, 1998||Get Started for $10||Get Started for $10|
|Bayer Hlthcare||CIPRO||ciprofloxacin hydrochloride||TABLET;ORAL||019537-002||Oct 22, 1987||Get Started for $10||Get Started for $10|
|Bayer Hlthcare||CIPRO||ciprofloxacin hydrochloride||TABLET;ORAL||019537-003||Oct 22, 1987||Get Started for $10||Get Started for $10|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>Patent No.||>Patent Expiration|
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