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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Chubb
Boehringer Ingelheim
Citi
Colorcon
Covington
Julphar
Mallinckrodt
Harvard Business School

Generated: June 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076558

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NDA 076558 describes CIPROFLOXACIN HYDROCHLORIDE, which is a drug marketed by Akorn Inc, Altaire Pharms Inc, Amring Pharms, Apotex Inc, Fdc Ltd, Rising Pharms Inc, Teligent, Watson Labs Inc, Ani Pharms Inc, Apotex, Aurobindo Pharma, Barr, Carlsbad, Dr Reddys Labs Ltd, Fosun Pharma, Hikma, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro Pharm, Teva, Unique Pharm Labs, and Watson Labs, and is included in twenty-six NDAs. It is available from sixty-nine suppliers. Additional details are available on the CIPROFLOXACIN HYDROCHLORIDE profile page.

The generic ingredient in CIPROFLOXACIN HYDROCHLORIDE is ciprofloxacin hydrochloride. There are thirty-one drug master file entries for this compound. Seventy-six suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.
Summary for 076558
Tradename:CIPROFLOXACIN HYDROCHLORIDE
Applicant:Hikma
Ingredient:ciprofloxacin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076558
Ingredient-typeQuinolones
Suppliers and Packaging for NDA: 076558
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076558 ANDA West-ward Pharmaceutical Corp 0143-2037 N 0143-2037-01
CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076558 ANDA West-ward Pharmaceutical Corp 0143-2037 N 0143-2037-05

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Jun 9, 2004TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:Jun 9, 2004TE:ABRLD:No

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 750MG BASE
Approval Date:Jun 9, 2004TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Covington
Queensland Health
Fish and Richardson
Deloitte
Boehringer Ingelheim
Argus Health
Federal Trade Commission
Chubb

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