FDA.reportPublic FDA data

Application 089407

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POLOCAINEMEPIVACAINE HYDROCHLORIDEINJECTABLE;INJECTION1%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4517PolocaineMEPIVACAINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-4517PolocaineMEPIVACAINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
51662-1534POLOCAINE (MEPIVACAINE HCl)POLOCAINE (MEPIVACAINE HCl)HF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1534POLOCAINE (MEPIVACAINE HCl)POLOCAINE (MEPIVACAINE HCl)HF Acquisition Co LLC, DBA HealthFirstANDACurrent
63323-283PolocaineMEPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCANDACurrent
63323-283PolocaineMEPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCANDACurrent
63323-283PolocaineMEPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCANDACurrent