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Fish and Richardson
Mallinckrodt
Merck
Chinese Patent Office
UBS
McKesson
Chubb
Cipla
AstraZeneca

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077809

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NDA 077809 describes CIPROFLOXACIN EXTENDED RELEASE, which is a drug marketed by Actavis Labs Fl Inc, Anchen Pharms, Dr Reddys Labs Ltd, Fosun Pharma, and Mylan Pharms Inc, and is included in six NDAs. It is available from three suppliers. Additional details are available on the CIPROFLOXACIN EXTENDED RELEASE profile page.

The generic ingredient in CIPROFLOXACIN EXTENDED RELEASE is ciprofloxacin; ciprofloxacin hydrochloride. There are thirty-one drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the ciprofloxacin; ciprofloxacin hydrochloride profile page.
Summary for 077809
Tradename:CIPROFLOXACIN EXTENDED RELEASE
Applicant:Actavis Labs Fl Inc
Ingredient:ciprofloxacin; ciprofloxacin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077809
Ingredient-typeQuinolones
Suppliers and Packaging for NDA: 077809
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPROFLOXACIN EXTENDED RELEASE ciprofloxacin; ciprofloxacin hydrochloride TABLET, EXTENDED RELEASE;ORAL 077809 ANDA Watson Pharma, Inc. 62037-938 N 62037-938-01
CIPROFLOXACIN EXTENDED RELEASE ciprofloxacin; ciprofloxacin hydrochloride TABLET, EXTENDED RELEASE;ORAL 077809 ANDA Watson Pharma, Inc. 62037-938 N 62037-938-05

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength425.2MG;EQ 574.9MG BASE
Approval Date:Nov 30, 2010TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Julphar
Fish and Richardson
Citi
US Army
Merck
Fuji
Boehringer Ingelheim
Cantor Fitzgerald

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