Application 076517

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARBOPLATINCARBOPLATININJECTABLE;INTRAVENOUS50MG/5ML (10MG/ML)NoNo
002CARBOPLATINCARBOPLATININJECTABLE;INTRAVENOUS150MG/15ML (10MG/ML)NoNo
003CARBOPLATINCARBOPLATININJECTABLE;INTRAVENOUS450MG/45ML (10MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61703-150CarboplatinCarboplatinHospira, Inc.ANDACurrent
61703-262CarboplatinCarboplatinHospira, Inc.ANDACurrent
61703-339CarboplatinCarboplatinHospira, Inc.ANDACurrent
61703-339CarboplatinCarboplatinHospira, Inc.ANDACurrent
61703-339CarboplatinCarboplatinHospira, Inc.ANDACurrent
61703-339CarboplatinCarboplatinHospira, Inc.ANDACurrent
61703-339CarboplatinCarboplatinHospira, Inc.ANDACurrent
61703-339CarboplatinCarboplatinHospira, Inc.ANDACurrent
61703-360CarboplatinCarboplatinHospira, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8921ORIG2004-10-18