FDA.reportPublic FDA data

Application 209967

Type
ANDA
Sponsor
RICONPHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDESOLUTION;INTRAVENOUS10MG/ML (10MG/ML)NoNo
002PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDESOLUTION;INTRAVENOUS50MG/5ML (10MG/ML)NoNo
003PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDESOLUTION;INTRAVENOUS100MG/10ML (10MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25021-315Phenylephrine HydrochloridePhenylephrine HydrochlorideSagent PharmaceuticalsANDACurrent
50742-478PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEIngenus Pharmaceuticals, LLCANDACurrent
50742-479PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEIngenus Pharmaceuticals, LLCANDACurrent
50742-480PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEIngenus Pharmaceuticals, LLCANDACurrent