Application 075811

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MESNAMESNAINJECTABLE;INTRAVENOUS100MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-733MesnaMESNAFresenius Kabi USA, LLCANDACurrent
63323-733MesnaMESNAFresenius Kabi USA, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22505ORIG2001-12-14
31024ORIG2001-04-26
18425ORIG2001-04-26