FDA.reportPublic FDA data

Application 213914

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SUNITINIB MALATESUNITINIB MALATECAPSULE;ORALEQ 12.5MG BASENoNo
002SUNITINIB MALATESUNITINIB MALATECAPSULE;ORALEQ 25MG BASENoNo
003SUNITINIB MALATESUNITINIB MALATECAPSULE;ORALEQ 37.5MG BASENoNo
004SUNITINIB MALATESUNITINIB MALATECAPSULE;ORALEQ 50MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-676Sunitinib malateSunitinib malateNorthStar RxLLCANDACurrent
16714-677Sunitinib malateSunitinib malateNorthStar RxLLCANDACurrent
16714-678Sunitinib malateSunitinib malateNorthStar RxLLCANDACurrent
16714-679Sunitinib malateSunitinib malateNorthStar RxLLCANDACurrent
63304-091Sunitinib malateSunitinib malateSun Pharmaceutical Industries Inc.ANDACurrent
63304-091Sunitinib malateSunitinib malateSun Pharmaceutical Industries Inc.ANDACurrent
63304-091Sunitinib malateSunitinib malateSun Pharmaceutical Industries Inc.ANDACurrent
63304-092Sunitinib malateSunitinib malateSun Pharmaceutical Industries Inc.ANDACurrent
63304-092Sunitinib malateSunitinib malateSun Pharmaceutical Industries Inc.ANDACurrent
63304-092Sunitinib malateSunitinib malateSun Pharmaceutical Industries Inc.ANDACurrent
63304-093Sunitinib malateSunitinib malateSun Pharmaceutical Industries Inc.ANDACurrent
63304-093Sunitinib malateSunitinib malateSun Pharmaceutical Industries Inc.ANDACurrent
63304-093Sunitinib malateSunitinib malateSun Pharmaceutical Industries Inc.ANDACurrent
63304-094Sunitinib malateSunitinib malateSun Pharmaceutical Industries Inc.ANDACurrent
63304-094Sunitinib malateSunitinib malateSun Pharmaceutical Industries Inc.ANDACurrent
63304-094Sunitinib malateSunitinib malateSun Pharmaceutical Industries Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68525ORIG2021-09-02