FDA.reportPublic FDA data

Application 208231

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARSENIC TRIOXIDEARSENIC TRIOXIDEINJECTABLE;INJECTION1MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-637Arsenic TrioxideArsenic TrioxideFresenius Kabi USA, LLCANDACurrent
63323-637Arsenic TrioxideArsenic TrioxideFresenius Kabi USA, LLCANDACurrent
63323-637Arsenic TrioxideArsenic TrioxideFresenius Kabi USA, LLCANDACurrent
63323-637Arsenic TrioxideArsenic TrioxideFresenius Kabi USA, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
55407ORIG2018-09-07