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Last Updated: November 21, 2024

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. Additional details are available on the CIPRO XR profile page.

The generic ingredient in CIPRO XR is ciprofloxacin; ciprofloxacin hydrochloride. There are thirty-four drug master file entries 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:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	212.6MG;EQ 287.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 13, 2002	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	425.2MG;EQ 574.9MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 28, 2003	TE:		RLD:	No

Expired US Patents for NDA 021473

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	CIPRO XR	ciprofloxacin; ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021473-001	Dec 13, 2002	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	CIPRO XR	ciprofloxacin; ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021473-002	Aug 28, 2003	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	CIPRO XR	ciprofloxacin; ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021473-002	Aug 28, 2003	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	CIPRO XR	ciprofloxacin; ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021473-002	Aug 28, 2003	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	CIPRO XR	ciprofloxacin; ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021473-001	Dec 13, 2002	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	CIPRO XR	ciprofloxacin; ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021473-001	Dec 13, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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