FDA.reportPublic FDA data

Application 203826

Type
NDA
Sponsor
WEST WARD PHARM CORP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDESOLUTION;INTRAVENOUS10MG/ML (10MG/ML)YesYes
002PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDESOLUTION;INTRAVENOUS50MG/5ML (10MG/ML)YesYes
003PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDESOLUTION;INTRAVENOUS100MG/10ML (10MG/ML)YesYes
004IMMPHENTIVPHENYLEPHRINE HYDROCHLORIDESOLUTION;INTRAVENOUS0.5MG/5ML (0.1MG/ML)YesYes
005IMMPHENTIVPHENYLEPHRINE HYDROCHLORIDESOLUTION;INTRAVENOUS1MG/10ML (0.1MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0641-6142Phenylephrine HydrochloridePhenylephrine HydrochlorideWest-Ward Pharmaceuticals Corp.NDACurrent
0641-6142Phenylephrine HydrochloridePhenylephrine HydrochlorideHikma Pharmaceuticals USA Inc.NDACurrent
0641-6142Phenylephrine HydrochloridePhenylephrine HydrochlorideHikma Pharmaceuticals USA Inc.NDACurrent
0641-6188Phenylephrine HydrochloridePhenylephrine HydrochlorideHikma Pharmaceuticals USA Inc.NDACurrent
0641-6188Phenylephrine HydrochloridePhenylephrine HydrochlorideHikma Pharmaceuticals USA Inc.NDACurrent
0641-6189Phenylephrine HydrochloridePhenylephrine HydrochlorideHikma Pharmaceuticals USA Inc.NDACurrent
0641-6189Phenylephrine HydrochloridePhenylephrine HydrochlorideHikma Pharmaceuticals USA Inc.NDACurrent
0641-6229Phenylephrine HydrochloridePhenylephrine HydrochlorideHikma Pharmaceuticals USA Inc.NDACurrent
0641-6229Phenylephrine HydrochloridePhenylephrine HydrochlorideWest-Ward Pharmaceuticals Corp.NDACurrent
51662-1249PHENYLEPHRINE HCIPHENYLEPHRINE HCIHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1249PHENYLEPHRINE HCIPHENYLEPHRINE HCIHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1249PHENYLEPHRINE HCIPHENYLEPHRINE HCIHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1249PHENYLEPHRINE HCIPHENYLEPHRINE HCIHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1249PHENYLEPHRINE HCIPHENYLEPHRINE HCIHF Acquisition Co LLC, DBA HealthFirstNDACurrent
52584-142PHENYLEPHRINE HYDROCHLORIDEphenylephrine hydrochlorideGeneral Injectables & Vaccines, IncNDACurrent
52584-142PHENYLEPHRINE HYDROCHLORIDEphenylephrine hydrochlorideGeneral Injectables & Vaccines, IncNDACurrent
55154-5129Phenylephrine HydrochloridePhenylephrine HydrochlorideCardinal HealthNDACurrent
55154-5129Phenylephrine HydrochloridePhenylephrine HydrochlorideCardinal HealthNDACurrent
70518-1038Phenylephrine HydrochloridePhenylephrine HydrochlorideREMEDYREPACK INC.NDACurrent
71872-7043Phenylephrine HydrochloridePhenylephrine HydrochlorideMedical Purchasing Solutions, LLCNDACurrent
72572-570Phenylephrine HydrochloridePhenylephrine HydrochlorideCivica, Inc.NDACurrent
72572-571Phenylephrine HydrochloridePhenylephrine HydrochlorideCivica, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73800SUPPL 2023-03-17
73799SUPPL 2023-03-17
73723SUPPL 2023-03-10
73722SUPPL 2023-03-10
64847SUPPL2020-10-06
45268SUPPL2016-09-12
45240SUPPL2016-09-06
44889ORIG2013-05-24
43445ORIG2013-05-24
10252ORIG2012-12-26
19494ORIG2012-12-21