FDA.reportPublic FDA data

Application 207324

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARBOPLATINCARBOPLATININJECTABLE;IV (INFUSION)50MG/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
47781-603CARBOPLATINCarboplatinAlvogen Inc.ANDACurrent
47781-604CARBOPLATINCarboplatinAlvogen Inc.ANDACurrent
47781-605CARBOPLATINCarboplatinAlvogen Inc.ANDACurrent
47781-606CARBOPLATINCarboplatinAlvogen Inc.ANDACurrent
68083-190CARBOPLATINCarboplatinGland Pharma LimitedANDACurrent
68083-191CARBOPLATINCarboplatinGland Pharma LimitedANDACurrent
68083-192CARBOPLATINCarboplatinGland Pharma LimitedANDACurrent
68083-193CARBOPLATINCarboplatinGland Pharma LimitedANDACurrent