FDA.reportPublic FDA data

Application 211081

Type
ANDA
Sponsor
APOLLO

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
61990-0211Phenylephrine hydrochloridePhenylephrine hydrochlorideApollo Pharmaceuticals Inc.ANDACurrent
61990-0212Phenylephrine hydrochloridePhenylephrine hydrochlorideApollo Pharmaceuticals Inc.ANDACurrent
61990-0213Phenylephrine hydrochloridePhenylephrine hydrochlorideApollo Pharmaceuticals Inc.ANDACurrent
71872-7231Phenylephrine hydrochloridePhenylephrine hydrochlorideMedical Purchasing Solutions, LLCANDACurrent
81284-211Phenylephrine hydrochloridePhenylephrine hydrochlorideProvepharm Inc.ANDACurrent
81284-211Phenylephrine hydrochloridePhenylephrine hydrochlorideProvepharm Inc.ANDACurrent
81284-212Phenylephrine hydrochloridePhenylephrine hydrochlorideProvepharm Inc.ANDACurrent
81284-212Phenylephrine hydrochloridePhenylephrine hydrochlorideProvepharm Inc.ANDACurrent
81284-213Phenylephrine hydrochloridePhenylephrine hydrochlorideProvepharm Inc.ANDACurrent
81284-213Phenylephrine hydrochloridePhenylephrine hydrochlorideProvepharm Inc.ANDACurrent