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Generated: December 15, 2017

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, 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 077809

Tradename:1
Applicant:1
Ingredient:1
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 62037-938-06 50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (62037-938-06)
CIPROFLOXACIN EXTENDED RELEASE ciprofloxacin; ciprofloxacin hydrochloride TABLET, EXTENDED RELEASE;ORAL 077809 ANDA Watson Pharma, Inc. 62037-938 62037-938-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (62037-938-01)

Summary 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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