FDA.reportPublic FDA data

Application 077269

Type
ANDA
Sponsor
PHARMACHEMIE BV

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARBOPLATINCARBOPLATININJECTABLE;INTRAVENOUS50MG/5ML (10MG/ML)NoYes
002CARBOPLATINCARBOPLATININJECTABLE;INTRAVENOUS150MG/15ML (10MG/ML)NoYes
003CARBOPLATINCARBOPLATININJECTABLE;INTRAVENOUS450MG/45ML (10MG/ML)NoYes
004CARBOPLATINCARBOPLATININJECTABLE;INTRAVENOUS600MG/60ML (10MG/ML)NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0703-4239CARBOplatinCARBOplatinTeva Parenteral Medicines, Inc.ANDACurrent
0703-4239CarboplatinCarboplatinTeva Parenteral Medicines, Inc.ANDACurrent
0703-4239CARBOplatinCARBOplatinTeva Parenteral Medicines, Inc.ANDACurrent
0703-4239CarboplatinCarboplatinTeva Parenteral Medicines, Inc.ANDACurrent
0703-4244CarboplatinCarboplatinTeva Parenteral Medicines, Inc.ANDACurrent
0703-4244CARBOplatinCARBOplatinTeva Parenteral Medicines, Inc.ANDACurrent
0703-4244CarboplatinCarboplatinTeva Parenteral Medicines, Inc.ANDACurrent
0703-4244CARBOplatinCARBOplatinTeva Parenteral Medicines, Inc.ANDACurrent
0703-4246CARBOplatinCARBOplatinTeva Parenteral Medicines, Inc.ANDACurrent
0703-4246CARBOplatinCARBOplatinTeva Parenteral Medicines, Inc.ANDACurrent
0703-4246CarboplatinCarboplatinTeva Parenteral Medicines, Inc.ANDACurrent
0703-4246CarboplatinCarboplatinTeva Parenteral Medicines, Inc.ANDACurrent
0703-4248CarboplatinCarboplatinTeva Parenteral Medicines, Inc.ANDACurrent
0703-4248CarboplatinCarboplatinTeva Parenteral Medicines, Inc.ANDACurrent
0703-4248CARBOplatinCARBOplatinTeva Parenteral Medicines, Inc.ANDACurrent
0703-4248CarboplatinCarboplatinTeva Parenteral Medicines, Inc.ANDACurrent
0703-4248CarboplatinCarboplatinTeva Parenteral Medicines, Inc.ANDACurrent
0703-4248CarboplatinCarboplatinTeva Parenteral Medicines, Inc.ANDACurrent
0703-4248CARBOplatinCARBOplatinTeva Parenteral Medicines, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9028ORIG2004-10-18