Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 22, 2019

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, Fdc Ltd, Rising, Rubicon, Teligent, Watson Labs Inc, Ani Pharms Inc, Aurobindo Pharma, Barr, Carlsbad, Chartwell Molecules, 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, and Yiling Pharm Ltd, and is included in twenty-seven NDAs. It is available from fifty-four suppliers. Additional details are available on the CIPROFLOXACIN HYDROCHLORIDE profile page.

The generic ingredient in CIPROFLOXACIN HYDROCHLORIDE is ciprofloxacin hydrochloride. There are thirty-four drug master file entries for this compound. Sixty-one 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
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 Hikma Pharmaceuticals USA Inc. 0143-9927 0143-9927-01 100 TABLET, FILM COATED in 1 BOTTLE (0143-9927-01)
CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076558 ANDA Hikma Pharmaceuticals USA Inc. 0143-9927 0143-9927-05 500 TABLET, FILM COATED in 1 BOTTLE (0143-9927-05)

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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