FDA.reportPublic FDA data

Application 213318

Type
ANDA
Sponsor
CAPLIN

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
65145-115PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDECaplin Steriles LimitedANDACurrent
65145-116PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDECaplin Steriles LimitedANDACurrent
65145-117PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDECaplin Steriles LimitedANDACurrent
70069-801PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDESomerset Therapeutics, LLCANDACurrent
70069-802PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDESomerset Therapeutics, LLCANDACurrent
70069-803PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDESomerset Therapeutics, LLCANDACurrent
70594-063Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDEXellia Pharmaceuticals USA LLCANDACurrent
70594-064Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDEXellia Pharmaceuticals USA LLCANDACurrent
70594-065Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDEXellia Pharmaceuticals USA LLCANDACurrent
71872-7273PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEMedical Purchasing Solutions, LLCANDACurrent