Application 020695

Type
NDA
Sponsor
OTSUKA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RAXARGREPAFLOXACIN HYDROCHLORIDETABLET;ORALEQ 200MG BASENoNo
002RAXARGREPAFLOXACIN HYDROCHLORIDETABLET;ORALEQ 400MG BASENoNo
003RAXARGREPAFLOXACIN HYDROCHLORIDETABLET;ORALEQ 600MG BASENoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
41560ORIG2004-07-15
41561SUPPL2004-06-28