FDA.reportPublic FDA data

Application 210123

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUOROURACILFLUOROURACILINJECTABLE;INJECTION500MG/10ML (50MG/ML)NoNo
002FLUOROURACILFLUOROURACILINJECTABLE;INJECTION1GM/20ML (50MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68001-524FluorouracilFluorouracilBluePoint LaboratoriesANDACurrent
68083-269FluorouracilFluorouracilGland Pharma LimitedANDACurrent
68083-269FluorouracilFluorouracilGland Pharma LimitedANDACurrent
68083-270FluorouracilFluorouracilGland Pharma LimitedANDACurrent
68083-270FluorouracilFluorouracilGland Pharma LimitedANDACurrent
70700-186FluorouracilFluorouracilXiromed LLCANDACurrent
70700-186FluorouracilFluorouracilXiromed LLCANDACurrent
70700-187FluorouracilFluorouracilXiromed LLCANDACurrent
70700-187FluorouracilFluorouracilXiromed LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85253SUPPL 2026-03-03
85235SUPPL 2026-03-03
77985SUPPL 2024-03-27
77976SUPPL 2024-03-26