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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Queensland Health
Chubb
Fuji
Healthtrust
Fish and Richardson
QuintilesIMS
Mallinckrodt
Dow

Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076089

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NDA 076089 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-seven 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-four suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.
Summary for 076089
Tradename:CIPROFLOXACIN HYDROCHLORIDE
Applicant:Ivax Sub Teva Pharms
Ingredient:ciprofloxacin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076089
Ingredient-typeQuinolones
Suppliers and Packaging for NDA: 076089
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076089 ANDA Teva Pharmaceuticals USA, Inc. 0172-5311 N 0172-5311-60
CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076089 ANDA Teva Pharmaceuticals USA, Inc. 0172-5312 N 0172-5312-42

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:

Covington
McKinsey
Julphar
Teva
Federal Trade Commission
Cerilliant
US Department of Justice
Fish and Richardson
Chubb

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