FDA.reportPublic FDA data

Application 210762

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FENTANYL CITRATE PRESERVATIVE FREEFENTANYL CITRATEINJECTABLE;INJECTIONEQ 0.05MG BASE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-806Fentanyl CitrateFentanyl CitrateFresenius Kabi USA, LLCANDACurrent
63323-806Fentanyl CitrateFentanyl CitrateFresenius Kabi USA, LLCANDACurrent
63323-806Fentanyl CitrateFentanyl CitrateFresenius Kabi USA, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59090ORIG2019-06-17