FDA.reportPublic FDA data

Application 210665

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDESOLUTION;INTRAVENOUS10MG/ML (10MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51662-1576PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1576PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
63323-751Phenylephrine HydrochloridePhenylephrine HydrochlorideFresenius Kabi USA, LLCANDACurrent
63323-751Phenylephrine HydrochloridePhenylephrine HydrochlorideFresenius Kabi USA, LLCANDACurrent
63323-751Phenylephrine HydrochloridePhenylephrine HydrochlorideFresenius Kabi USA, LLCANDACurrent
63323-751Phenylephrine HydrochloridePhenylephrine HydrochlorideFresenius Kabi USA, LLCANDACurrent