FDA.reportPublic FDA data

Application 212993

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDEINJECTABLE;INJECTION40MG/2ML (20MG/ML)NoNo
002IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDEINJECTABLE;INJECTION100MG/5ML (20MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-027Irinotecan hydrochlorideIrinotecan hydrochlorideNorthstar Rx LLCANDACurrent
16714-027Irinotecan hydrochlorideIrinotecan hydrochlorideNorthstar Rx LLCANDACurrent
16714-027Irinotecan hydrochlorideIrinotecan hydrochlorideNorthstar Rx LLCANDACurrent
16714-131Irinotecan hydrochlorideIrinotecan hydrochlorideNorthstar Rx LLCANDACurrent
16714-131Irinotecan hydrochlorideIrinotecan hydrochlorideNorthstar Rx LLCANDACurrent
16714-131Irinotecan hydrochlorideIrinotecan hydrochlorideNorthstar Rx LLCANDACurrent
68001-480Irinotecan hydrochloideIrinotecan hydrochloideBluePoint LaboratoriesANDACurrent
68001-480Irinotecan hydrochloideIrinotecan hydrochloideBluePoint LaboratoriesANDACurrent
68001-480Irinotecan hydrochloideIrinotecan hydrochloideBluePoint LaboratoriesANDACurrent
68001-480Irinotecan hydrochloideIrinotecan hydrochloideBluePoint LaboratoriesANDACurrent
68001-480Irinotecan hydrochloideIrinotecan hydrochloideBluePoint LaboratoriesANDACurrent
68083-381Irinotecan hydrochloideIrinotecan hydrochloideGland Pharma LimitedANDACurrent
68083-381Irinotecan hydrochloideIrinotecan hydrochloideGland Pharma LimitedANDACurrent
68083-381Irinotecan hydrochloideIrinotecan hydrochloideGland Pharma LimitedANDACurrent
68083-381Irinotecan hydrochloideIrinotecan hydrochloideGland Pharma LimitedANDACurrent
68083-382Irinotecan hydrochlorideIrinotecan hydrochlorideGland Pharma LimitedANDACurrent
68083-382Irinotecan hydrochlorideIrinotecan hydrochlorideGland Pharma LimitedANDACurrent
68083-382Irinotecan hydrochlorideIrinotecan hydrochlorideGland Pharma LimitedANDACurrent
68083-382Irinotecan hydrochlorideIrinotecan hydrochlorideGland Pharma LimitedANDACurrent
70700-169Irinotecan hydrochloideIrinotecan hydrochloideXiromed LLCANDACurrent
70700-169Irinotecan hydrochloideIrinotecan hydrochloideXiromed LLCANDACurrent
70700-169Irinotecan hydrochloideIrinotecan hydrochloideXiromed LLCANDACurrent
70700-170Irinotecan hydrochlorideIrinotecan hydrochlorideXiromed LLCANDACurrent
70700-170Irinotecan hydrochlorideIrinotecan hydrochlorideXiromed LLCANDACurrent
70700-170Irinotecan hydrochlorideIrinotecan hydrochlorideXiromed LLCANDACurrent