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Serving leading biopharmaceutical companies globally:

McKesson
Cipla
Queensland Health
Fish and Richardson
Accenture
Dow
US Department of Justice
Julphar
Argus Health
Novartis

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077701

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NDA 077701 describes CIPROFLOXACIN EXTENDED RELEASE, which is a drug marketed by Actavis Labs Fl Inc, Anchen Pharms, Dr Reddys Labs Ltd, Mylan Pharms Inc, and Sandoz, 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 077701
Tradename:CIPROFLOXACIN EXTENDED RELEASE
Applicant:Dr Reddys Labs Ltd
Ingredient:ciprofloxacin; ciprofloxacin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077701
Ingredient-typeQuinolones
Suppliers and Packaging for NDA: 077701
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPROFLOXACIN EXTENDED RELEASE ciprofloxacin; ciprofloxacin hydrochloride TABLET, EXTENDED RELEASE;ORAL 077701 ANDA Dr. Reddy's Laboratories Limited 55111-423 55111-423-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-423-05)
CIPROFLOXACIN EXTENDED RELEASE ciprofloxacin; ciprofloxacin hydrochloride TABLET, EXTENDED RELEASE;ORAL 077701 ANDA Dr. Reddy's Laboratories Limited 55111-423 55111-423-78 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOX, UNIT-DOSE (55111-423-78)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength425.2MG;EQ 574.9MG BASE
Approval Date:Mar 26, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength212.6MG;EQ 287.5MG BASE
Approval Date:Oct 31, 2007TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Julphar
UBS
Cipla
Medtronic
Moodys
Covington
Healthtrust
Fish and Richardson
Citi

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