FDA.report

Application 019316

Type
NDA
Sponsor
FRESENIUS KABI USA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001MAGNESIUM SULFATEMAGNESIUM SULFATESOLUTION;INTRAMUSCULAR, INTRAVENOUS5GM/10ML (500MG/ML)YesYes
002MAGNESIUM SULFATEMAGNESIUM SULFATESOLUTION;INTRAMUSCULAR, INTRAVENOUS1GM/2ML (500MG/ML)YesYes
003MAGNESIUM SULFATEMAGNESIUM SULFATESOLUTION;INTRAMUSCULAR, INTRAVENOUS10GM/20ML (500MG/ML)YesYes
004MAGNESIUM SULFATEMAGNESIUM SULFATESOLUTION;INTRAMUSCULAR, INTRAVENOUS25GM/50ML (500MG/ML)YesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9902Magnesium SulfateMagnesium SulfateHenry Schein, Inc.NDACurrent
0404-9902Magnesium SulfateMagnesium SulfateHenry Schein, Inc.NDACurrent
0404-9902Magnesium SulfateMagnesium SulfateHenry Schein, Inc.NDACurrent
51662-1372MAGNESIUM SULFATEMAGNESIUM SULFATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1372MAGNESIUM SULFATEMAGNESIUM SULFATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1372MAGNESIUM SULFATEMAGNESIUM SULFATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1390MAGNESIUM SULFATEMAGNESIUM SULFATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1390MAGNESIUM SULFATEMAGNESIUM SULFATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1451MAGNESIUM SULFATEMAGNESIUM SULFATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1451MAGNESIUM SULFATEMAGNESIUM SULFATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1451MAGNESIUM SULFATEMAGNESIUM SULFATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
52584-064Magnesium SulfateMagnesium SulfateGeneral Injectables and Vaccines, Inc.NDACurrent
52584-064Magnesium SulfateMagnesium SulfateGeneral Injectables and Vaccines, Inc.NDACurrent
52584-064Magnesium SulfateMagnesium SulfateGeneral Injectables and Vaccines, Inc.NDACurrent
52584-642Magnesium SulfateMagnesium SulfateGeneral Injectables and Vaccines, Inc.NDACurrent
52584-642Magnesium SulfateMagnesium SulfateGeneral Injectables and Vaccines, Inc.NDACurrent
52584-642Magnesium SulfateMagnesium SulfateGeneral Injectables and Vaccines, Inc.NDACurrent
52584-642Magnesium SulfateMagnesium SulfateGeneral Injectables and Vaccines, Inc.NDACurrent
52584-642Magnesium SulfateMagnesium SulfateGeneral Injectables and Vaccines, Inc.NDACurrent
55154-9358Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATECardinal HealthNDACurrent
63323-064Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEFresenius Kabi USA, LLCNDACurrent
63323-064Magnesium SulfateMagnesium Sulfate HeptahydrateFresenius Kabi USA, LLCNDACurrent
63323-064Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEFresenius Kabi USA, LLCNDACurrent
63323-064Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEFresenius Kabi USA, LLCNDACurrent
63323-064Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEFresenius Kabi USA, LLCNDACurrent
63323-064Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEFresenius Kabi USA, LLCNDACurrent
63323-064Magnesium SulfateMagnesium Sulfate HeptahydrateFresenius Kabi USA, LLCNDACurrent
63323-642Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEFresenius Kabi USA, LLCNDACurrent
63323-642Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEFresenius Kabi USA, LLCNDACurrent
63323-642Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEFresenius Kabi USA, LLCNDACurrent
70518-0950Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEREMEDYREPACK INC.NDACurrent
71872-7055Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEMedical Purchasing Solutions, LLCNDACurrent
71872-7055Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEMedical Purchasing Solutions, LLCNDACurrent
71872-7142Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEMedical Purchasing Solutions, LLCNDACurrent
71872-7142Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEMedical Purchasing Solutions, LLCNDACurrent
71872-7229Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEMedical Purchasing Solutions, LLCNDACurrent

Documents

DocumentSubmission typeDate
52914SUPPL2018-03-12
52825SUPPL2018-03-06
11475SUPPL2013-06-04
1283SUPPL2013-05-30
17358SUPPL2006-12-28
33723SUPPL2006-12-14