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QuintilesIMS
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Cipla
US Army
Moodys
Chubb
Deloitte
Queensland Health
Julphar

Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077568

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NDA 077568 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 077568
Tradename:CIPROFLOXACIN HYDROCHLORIDE
Applicant:Fdc Ltd
Ingredient:ciprofloxacin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077568
Ingredient-typeQuinolones
Suppliers and Packaging for NDA: 077568
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 077568 ANDA Pack Pharmaceuticals, LLC 16571-135 E 16571-135-10
CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 077568 ANDA Pack Pharmaceuticals, LLC 16571-135 E 16571-135-50

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.3% BASE
Approval Date:Jun 30, 2008TE:ATRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Healthtrust
Express Scripts
Baxter
Teva
AstraZeneca
Colorcon
Queensland Health
Accenture

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