FDA.reportPublic FDA data

Application 211078

Type
ANDA
Sponsor
AMNEAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDESOLUTION;INTRAVENOUS50MG/5ML (10MG/ML)NoNo
002PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDESOLUTION;INTRAVENOUS100MG/10ML (10MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70121-1578Phenylephrine hydrochloridePhenylephrine hydrochlorideAmneal Pharmaceuticals LLCANDACurrent
70121-1578Phenylephrine hydrochloridePhenylephrine hydrochlorideAmneal Pharmaceuticals LLCANDACurrent
70121-1578Phenylephrine hydrochloridePhenylephrine hydrochlorideAmneal Biosciences LLCANDACurrent
70121-1578Phenylephrine hydrochloridePhenylephrine hydrochlorideAmneal Pharmaceuticals LLCANDACurrent
70121-1579Phenylephrine hydrochloridePhenylephrine hydrochlorideAmneal Pharmaceuticals LLCANDACurrent
70121-1579Phenylephrine hydrochloridePhenylephrine hydrochlorideAmneal Pharmaceuticals LLCANDACurrent
70121-1579Phenylephrine hydrochloridePhenylephrine hydrochlorideAmneal Biosciences LLCANDACurrent
70121-1579Phenylephrine hydrochloridePhenylephrine hydrochlorideAmneal Pharmaceuticals LLCANDACurrent