FDA.reportPublic FDA data

Application 080618

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PYRIDOXINE HYDROCHLORIDEPYRIDOXINE HYDROCHLORIDEINJECTABLE;INJECTION100MG/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51662-1410PYRIDOXINE HCIPYRIDOXINE HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1410PYRIDOXINE HCIPYRIDOXINE HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1410PYRIDOXINE HCIPYRIDOXINE HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
63323-180Pyridoxine HydrochloridePYRIDOXINE HYDROCHLORIDEFresenius Kabi USA, LLCANDACurrent
63323-180Pyridoxine HydrochloridePYRIDOXINE HYDROCHLORIDEFresenius Kabi USA, LLCANDACurrent