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Last Updated: March 19, 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:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength212.6MG;EQ 287.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Dec 13, 2002TE:RLD:No

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RELEASE;ORALStrength425.2MG;EQ 574.9MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Aug 28, 2003TE:RLD:No

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

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