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Abbreviated New Drug Application (ANDA): 213914
Company: SUN PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUNITINIB MALATE SUNITINIB MALATE EQ 12.5MG BASE CAPSULE;ORAL Prescription AB No No
SUNITINIB MALATE SUNITINIB MALATE EQ 25MG BASE CAPSULE;ORAL Prescription AB No No
SUNITINIB MALATE SUNITINIB MALATE EQ 37.5MG BASE CAPSULE;ORAL Prescription AB No No
SUNITINIB MALATE SUNITINIB MALATE EQ 50MG BASE CAPSULE;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/16/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213914Orig1s000ltr.pdf

SUNITINIB MALATE

CAPSULE;ORAL; EQ 12.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SUNITINIB MALATE SUNITINIB MALATE EQ 12.5MG BASE CAPSULE;ORAL Prescription No AB 215843 DR REDDYS
SUNITINIB MALATE SUNITINIB MALATE EQ 12.5MG BASE CAPSULE;ORAL Prescription No AB 201275 MYLAN
SUNITINIB MALATE SUNITINIB MALATE EQ 12.5MG BASE CAPSULE;ORAL Prescription No AB 213914 SUN PHARM
SUNITINIB MALATE SUNITINIB MALATE EQ 12.5MG BASE CAPSULE;ORAL Prescription No AB 213803 TEVA PHARMS USA
SUTENT SUNITINIB MALATE EQ 12.5MG BASE CAPSULE;ORAL Prescription Yes AB 021938 CPPI CV

CAPSULE;ORAL; EQ 25MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SUNITINIB MALATE SUNITINIB MALATE EQ 25MG BASE CAPSULE;ORAL Prescription No AB 215843 DR REDDYS
SUNITINIB MALATE SUNITINIB MALATE EQ 25MG BASE CAPSULE;ORAL Prescription No AB 201275 MYLAN
SUNITINIB MALATE SUNITINIB MALATE EQ 25MG BASE CAPSULE;ORAL Prescription No AB 213914 SUN PHARM
SUNITINIB MALATE SUNITINIB MALATE EQ 25MG BASE CAPSULE;ORAL Prescription No AB 213803 TEVA PHARMS USA
SUTENT SUNITINIB MALATE EQ 25MG BASE CAPSULE;ORAL Prescription Yes AB 021938 CPPI CV

CAPSULE;ORAL; EQ 37.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SUNITINIB MALATE SUNITINIB MALATE EQ 37.5MG BASE CAPSULE;ORAL Prescription No AB 215843 DR REDDYS
SUNITINIB MALATE SUNITINIB MALATE EQ 37.5MG BASE CAPSULE;ORAL Prescription No AB 201275 MYLAN
SUNITINIB MALATE SUNITINIB MALATE EQ 37.5MG BASE CAPSULE;ORAL Prescription No AB 213914 SUN PHARM
SUNITINIB MALATE SUNITINIB MALATE EQ 37.5MG BASE CAPSULE;ORAL Prescription No AB 213803 TEVA PHARMS USA
SUTENT SUNITINIB MALATE EQ 37.5MG BASE CAPSULE;ORAL Prescription Yes AB 021938 CPPI CV

CAPSULE;ORAL; EQ 50MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SUNITINIB MALATE SUNITINIB MALATE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 215843 DR REDDYS
SUNITINIB MALATE SUNITINIB MALATE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 201275 MYLAN
SUNITINIB MALATE SUNITINIB MALATE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 213914 SUN PHARM
SUNITINIB MALATE SUNITINIB MALATE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 213803 TEVA PHARMS USA
SUTENT SUNITINIB MALATE EQ 50MG BASE CAPSULE;ORAL Prescription Yes AB 021938 CPPI CV
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