Application 210025

Type
ANDA
Sponsor
PAR STERILE PRODUCTS

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
42023-213Phenylephrine hydrochloridePhenylephrine hydrochloridePar Pharmaceutical, Inc.ANDACurrent
42023-213Phenylephrine hydrochloridePhenylephrine hydrochloridePar Pharmaceutical, Inc.ANDACurrent
42023-213Phenylephrine hydrochloridePhenylephrine hydrochloridePar Pharmaceutical, Inc.ANDACurrent
42023-213Phenylephrine hydrochloridePhenylephrine hydrochloridePar Pharmaceutical, Inc.ANDACurrent
42023-213Phenylephrine hydrochloridePhenylephrine hydrochloridePar Pharmaceutical, Inc.ANDACurrent
42023-214Phenylephrine hydrochloridePhenylephrine hydrochloridePar Pharmaceutical, Inc.ANDACurrent
42023-214Phenylephrine hydrochloridePhenylephrine hydrochloridePar Pharmaceutical, Inc.ANDACurrent
42023-214Phenylephrine hydrochloridePhenylephrine hydrochloridePar Pharmaceutical, Inc.ANDACurrent
42023-214Phenylephrine hydrochloridePhenylephrine hydrochloridePar Pharmaceutical, Inc.ANDACurrent
42023-214Phenylephrine hydrochloridePhenylephrine hydrochloridePar Pharmaceutical, Inc.ANDACurrent
42023-214Phenylephrine hydrochloridePhenylephrine hydrochloridePar Pharmaceutical, Inc.ANDACurrent
42023-215Phenylephrine hydrochloridePhenylephrine hydrochloridePar Pharmaceutical, Inc.ANDACurrent
42023-215Phenylephrine hydrochloridePhenylephrine hydrochloridePar Pharmaceutical, Inc.ANDACurrent
42023-215Phenylephrine hydrochloridePhenylephrine hydrochloridePar Pharmaceutical, Inc.ANDACurrent
42023-215Phenylephrine hydrochloridePhenylephrine hydrochloridePar Pharmaceutical, Inc.ANDACurrent
42023-215Phenylephrine hydrochloridePhenylephrine hydrochloridePar Pharmaceutical, Inc.ANDACurrent
42023-215Phenylephrine hydrochloridePhenylephrine hydrochloridePar Pharmaceutical, Inc.ANDACurrent