Orange Book product · Brand (NDA)
CIPRO XR
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE
At a glance
Dec 13, 2002
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 13, 2002
23 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE
Strength
212.6MG;EQ 287.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 021473
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 2010CIPROFLOXACIN EXTENDED RELEASEGeneric (ANDA)
ANDA 077809 · ANI PHARMS
- 2007CIPROFLOXACIN EXTENDED RELEASEGeneric (ANDA)
ANDA 078712 · FOSUN PHARMA
- 2007CIPROFLOXACIN EXTENDED RELEASEGeneric (ANDA)
ANDA 078166 · PH HEALTH
- 2007CIPROFLOXACIN EXTENDED RELEASEGeneric (ANDA)
ANDA 077701 · DR REDDYS LABS LTD
- 2007CIPROFLOXACIN EXTENDED RELEASEGeneric (ANDA)
ANDA 078183 · RISING
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
