FDA.reportPublic FDA data

Application 210697

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

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
55150-301PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEAuroMedics Pharma LLCANDACurrent
55150-301PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEAuroMedics Pharma LLCANDACurrent
55150-302PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEAuroMedics Pharma LLCANDACurrent
55150-302PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEAuroMedics Pharma LLCANDACurrent