FDA.reportPublic FDA data

Application 211079

Type
ANDA
Sponsor
AMNEAL

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
0404-9931Phenylephrine HydrochloridePhenylephrine HydrochlorideHenry Schein, Inc.ANDACurrent
0404-9931Phenylephrine HydrochloridePhenylephrine HydrochlorideHenry Schein, Inc.ANDACurrent
52584-577Phenylephrine HydrochloridePhenylephrine HydrochlorideGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-577Phenylephrine HydrochloridePhenylephrine HydrochlorideGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-577Phenylephrine HydrochloridePhenylephrine HydrochlorideGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-577Phenylephrine HydrochloridePhenylephrine HydrochlorideGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-577Phenylephrine HydrochloridePhenylephrine HydrochlorideGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-577Phenylephrine HydrochloridePhenylephrine HydrochlorideGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-577Phenylephrine HydrochloridePhenylephrine HydrochlorideGeneral Injectables and Vaccines, Inc.ANDACurrent
55154-8226Phenylephrine hydrochloridePhenylephrine hydrochlorideCardinal HealthANDACurrent
55154-8226Phenylephrine hydrochloridePhenylephrine hydrochlorideCardinal HealthANDACurrent
55154-8226Phenylephrine hydrochloridePhenylephrine hydrochlorideCardinal Health 107, LLCANDACurrent
70121-1577Phenylephrine hydrochloridePhenylephrine hydrochlorideAmneal Biosciences LLCANDACurrent
70121-1577Phenylephrine hydrochloridePhenylephrine hydrochlorideAmneal Pharmaceuticals LLCANDACurrent
70121-1577Phenylephrine hydrochloridePhenylephrine hydrochlorideAmneal Pharmaceuticals LLCANDACurrent
70121-1577Phenylephrine hydrochloridePhenylephrine hydrochlorideAmneal Pharmaceuticals LLCANDACurrent
71872-7159Phenylephrine hydrochloridePhenylephrine hydrochlorideMedical Purchasing Solutions, LLCANDACurrent