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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Dow
QuintilesIMS
Colorcon
Fish and Richardson
Farmers Insurance
Moodys
Argus Health
Daiichi Sankyo

Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021473

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NDA 021473 describes CIPRO XR, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the CIPRO XR profile page.

The generic ingredient in CIPRO XR 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 021473
Tradename:CIPRO XR
Applicant:Bayer Hlthcare
Ingredient:ciprofloxacin; ciprofloxacin hydrochloride
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 021473
Ingredient-typeQuinolones
Suppliers and Packaging for NDA: 021473
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPRO XR ciprofloxacin; ciprofloxacin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021473 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-788 N 50419-788-01
CIPRO XR ciprofloxacin; ciprofloxacin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021473 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-788 N 50419-788-00

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength212.6MG;EQ 287.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 13, 2002TE:RLD:No
Patent:➤ Try a Free TrialPatent Expiration:Dec 23, 2021Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free TrialPatent Expiration:Dec 23, 2021Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength425.2MG;EQ 574.9MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Aug 28, 2003TE:RLD:No
Patent:➤ Try a Free TrialPatent Expiration:Dec 23, 2021Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021473

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare CIPRO XR ciprofloxacin; ciprofloxacin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021473-002 Aug 28, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Bayer Hlthcare CIPRO XR ciprofloxacin; ciprofloxacin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021473-001 Dec 13, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Johnson and Johnson
Merck
Express Scripts
Citi
Harvard Business School
Chinese Patent Office
QuintilesIMS
Covington

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