Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213914
Company: SUN PHARM

Products on ANDA 213914

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213914

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

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/21/2023	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 213914

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	218615	EUGIA PHARMA
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	218024	NATCO PHARMA
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	218615	EUGIA PHARMA
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	218024	NATCO PHARMA
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	218615	EUGIA PHARMA
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	218024	NATCO PHARMA
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	218615	EUGIA PHARMA
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	218024	NATCO PHARMA
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