FDA.reportPublic FDA data

Application 070968

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SENSORCAINEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATEINJECTABLE;INJECTION0.5%;0.0091MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51662-1399BUPIVACAINE HCI AND EPINEPHRINEBUPIVACAINE HCI AND EPINEPHRINEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1399BUPIVACAINE HCI AND EPINEPHRINEBUPIVACAINE HCI AND EPINEPHRINEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1399BUPIVACAINE HCI AND EPINEPHRINEBUPIVACAINE HCI AND EPINEPHRINEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
63323-463SENSORCAINEBUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCANDACurrent
63323-463SENSORCAINEBUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCANDACurrent