FDA.reportPublic FDA data

Application 070966

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SENSORCAINEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATEINJECTABLE;INJECTION0.25%;0.0091MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-468SENSORCAINEBUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCANDACurrent
63323-468SENSORCAINEBUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCANDACurrent