FDA.reportPublic FDA data

Application 089454

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROTAMINE SULFATEPROTAMINE SULFATEINJECTABLE;INJECTION10MG/MLNoYes
002PROTAMINE SULFATEPROTAMINE SULFATESOLUTION;INTRAVENOUS250MG/25ML (10MG/ML)NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51662-1414PROTAMINE SULFATEPROTAMINE SULFATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1414PROTAMINE SULFATEPROTAMINE SULFATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
63323-229Protamine SulfatePROTAMINE SULFATEFresenius Kabi USA, LLCANDACurrent
63323-229Protamine SulfatePROTAMINE SULFATEFresenius Kabi USA, LLCANDACurrent
63323-229Protamine SulfatePROTAMINE SULFATEFresenius Kabi USA, LLCANDACurrent
63323-229Protamine SulfatePROTAMINE SULFATEFresenius Kabi USA, LLCANDACurrent
63323-229Protamine SulfatePROTAMINE SULFATEFresenius Kabi USA, LLCANDACurrent