FDA.reportPublic FDA data

Application 077861

Type
ANDA
Sponsor
CIPLA LTD

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
004CARBOPLATINCARBOPLATININJECTABLE;INTRAVENOUS600MG/60ML (10MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69097-239CARBOPLATINCARBOPLATINCipla USA Inc.ANDACurrent
69097-241CARBOPLATINCARBOPLATINCipla USA Inc.ANDACurrent
69097-242CARBOPLATINCARBOPLATINCipla USA Inc.ANDACurrent
69097-243CARBOPLATINCARBOPLATINCipla USA Inc.ANDACurrent