Application 021554

Type
NDA
Sponsor
BAYER PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CIPRO XRCIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDETABLET, EXTENDED RELEASE; ORAL212.6MG; EQ 287.5MG BASENoNo
002CIPRO XRCIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDETABLET, EXTENDED RELEASE; ORAL425.2MG; EQ 574.9MG BASENoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44480ORIG2016-02-03
21732ORIG2005-12-01
37214ORIG2003-09-09
28105ORIG2003-09-09