FDA.reportPublic FDA data

Application 071413

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUPHENAZINE DECANOATEFLUPHENAZINE DECANOATEINJECTABLE;INJECTION25MG/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-272Fluphenazine DecanoateFLUPHENAZINE DECANOATEFresenius Kabi USA, LLCANDACurrent
63323-272Fluphenazine DecanoateFLUPHENAZINE DECANOATEFresenius Kabi USA, LLCANDACurrent
64725-0272Fluphenazine DecanoateFLUPHENAZINE DECANOATETYA PharmaceuticalsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30668SUPPL2011-10-07
18346SUPPL2011-10-06