FDA.reportPublic FDA data

Application 078591

Type
ANDA
Sponsor
HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDEINJECTABLE;INJECTION10MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-2634Hydromorphone HydrochlorideHydromorphone HydrochlorideHospira, Inc.ANDACurrent
0409-2634Hydromorphone HydrochlorideHydromorphone HydrochlorideHospira, Inc.ANDACurrent
0409-2634Hydromorphone HydrochlorideHydromorphone HydrochlorideHospira, Inc.ANDACurrent
0409-2634Hydromorphone HydrochlorideHydromorphone HydrochlorideHospira, Inc.ANDACurrent
0409-2634Hydromorphone HydrochlorideHydromorphone HydrochlorideHospira, Inc.ANDACurrent
0409-2634Hydromorphone HydrochlorideHydromorphone HydrochlorideHospira, Inc.ANDACurrent
0409-2634Hydromorphone HydrochlorideHydromorphone HydrochlorideHospira, Inc.ANDACurrent
0703-0018Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDETeva Parenteral Medicines, Inc.ANDACurrent
0703-0018Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDETeva Parenteral Medicines, Inc.ANDACurrent
0703-0018Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDETeva Parenteral Medicines, Inc.ANDACurrent
0703-0018Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDETeva Parenteral Medicines, Inc.ANDACurrent
0703-0018Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDETeva Parenteral Medicines, Inc.ANDACurrent
0703-0018Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDETeva Parenteral Medicines, Inc.ANDACurrent
0703-0110Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDETeva Parenteral Medicines, Inc.ANDACurrent
0703-0110Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDETeva Parenteral Medicines, Inc.ANDACurrent
0703-0110Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDETeva Parenteral Medicines, Inc.ANDACurrent
0703-0110Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDETeva Parenteral Medicines, Inc.ANDACurrent
0703-0110Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDETeva Parenteral Medicines, Inc.ANDACurrent
0703-0110Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDETeva Parenteral Medicines, Inc.ANDACurrent
0703-0113Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDETeva Parenteral Medicines, Inc.ANDACurrent
0703-0113Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDETeva Parenteral Medicines, Inc.ANDACurrent
0703-0113Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDETeva Parenteral Medicines, Inc.ANDACurrent
0703-0113Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDETeva Parenteral Medicines, Inc.ANDACurrent
0703-0113Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDETeva Parenteral Medicines, Inc.ANDACurrent
0703-0113Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDETeva Parenteral Medicines, Inc.ANDACurrent