FDA.reportPublic FDA data

Application 210334

Type
ANDA
Sponsor
MEITHEAL

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
69097-534PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDECipla USA Inc.ANDACurrent
69097-534PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDECipla USA Inc.ANDACurrent
71288-807PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEMeitheal Pharmaceuticals Inc.ANDACurrent
71288-807PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEMeitheal Pharmaceuticals Inc.ANDACurrent
71288-807PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEMeitheal Pharmaceuticals Inc.ANDACurrent
71288-807PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEMeitheal Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54146ORIG2018-05-11