FDA.reportPublic FDA data

Application 075841

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PAMIDRONATE DISODIUMPAMIDRONATE DISODIUMINJECTABLE;INJECTION30MG/10ML (3MG/ML)NoYes
002PAMIDRONATE DISODIUMPAMIDRONATE DISODIUMINJECTABLE;INJECTION60MG/10ML (6MG/ML)NoYes
003PAMIDRONATE DISODIUMPAMIDRONATE DISODIUMINJECTABLE;INJECTION90MG/10ML (9MG/ML)NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61703-324Pamidronate DisodiumPAMIDRONATE DISODIUMHospira, Inc.ANDACurrent
61703-324Pamidronate DisodiumPAMIDRONATE DISODIUMHospira, Inc.ANDACurrent
61703-324Pamidronate DisodiumPAMIDRONATE DISODIUMHospira, Inc.ANDACurrent
61703-324Pamidronate DisodiumPAMIDRONATE DISODIUMHospira, Inc.ANDACurrent
61703-324Pamidronate DisodiumPAMIDRONATE DISODIUMHospira, Inc.ANDACurrent
61703-325Pamidronate DisodiumPAMIDRONATE DISODIUMHospira, Inc.ANDACurrent
61703-325Pamidronate DisodiumPAMIDRONATE DISODIUMHospira, Inc.ANDACurrent
61703-325Pamidronate DisodiumPAMIDRONATE DISODIUMHospira, Inc.ANDACurrent
61703-325Pamidronate DisodiumPAMIDRONATE DISODIUMHospira, Inc.ANDACurrent
61703-325Pamidronate DisodiumPAMIDRONATE DISODIUMHospira, Inc.ANDACurrent
61703-326Pamidronate DisodiumPAMIDRONATE DISODIUMHospira, Inc.ANDACurrent
61703-326Pamidronate DisodiumPAMIDRONATE DISODIUMHospira, Inc.ANDACurrent
61703-326Pamidronate DisodiumPAMIDRONATE DISODIUMHospira, Inc.ANDACurrent
61703-326Pamidronate DisodiumPAMIDRONATE DISODIUMHospira, Inc.ANDACurrent
61703-326Pamidronate DisodiumPAMIDRONATE DISODIUMHospira, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44272ORIG2008-01-07
43029ORIG2006-04-20