NDC 43598-046

SUNITINIB MALATE

Sunitinib Malate

SUNITINIB MALATE is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Dr.reddys Laboratories Inc. The primary component is Sunitinib Malate.

Product ID43598-046_64f82125-61a8-4e9c-2633-903ec6d5e9fc
NDC43598-046
Product TypeHuman Prescription Drug
Proprietary NameSUNITINIB MALATE
Generic NameSunitinib Malate
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2022-11-30
Marketing CategoryANDA /
Application NumberANDA215843
Labeler NameDr.Reddys Laboratories Inc
Substance NameSUNITINIB MALATE
Active Ingredient Strength25 mg/1
Pharm ClassesKinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 43598-046-28

4 BLISTER PACK in 1 CARTON (43598-046-28) > 7 CAPSULE in 1 BLISTER PACK (43598-046-70)
Marketing Start Date2022-11-30
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "SUNITINIB MALATE" or generic name "Sunitinib Malate"

NDCBrand NameGeneric Name
0093-8199Sunitinib MalateSunitinib Malate
0093-8224Sunitinib MalateSunitinib Malate
0093-8229Sunitinib MalateSunitinib Malate
0093-8231Sunitinib MalateSunitinib Malate
0378-6678Sunitinib Malatesunitinib malate
0378-6679Sunitinib Malatesunitinib malate
0378-6680Sunitinib Malatesunitinib malate
0378-6681Sunitinib Malatesunitinib malate
16714-676Sunitinib malateSunitinib malate
16714-677Sunitinib malateSunitinib malate
0069-0550SUTENTSunitinib malate
0069-0770SUTENTSunitinib malate
0069-0830SUTENTSunitinib malate
0069-0980SUTENTSunitinib malate

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.