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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078340
Company: SUN PHARM

Products on ANDA 078340

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	AB	No	No
IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 400MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078340

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/03/2015	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078340Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/08/2019	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
04/08/2019	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
04/08/2019	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
04/08/2019	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
04/08/2019	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
04/08/2019	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078340

IMATINIB MESYLATE

TABLET;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GLEEVEC	IMATINIB MESYLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	Yes	AB	021588	NOVARTIS
IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	079179	APOTEX
IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	208429	CHARTWELL RX
IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	206547	DR REDDYS
IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	212773	EUGIA PHARMA
IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	204644	MYLAN
IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	207818	NATCO PHARMA LTD
IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	212135	QILU PHARM HAINAN
IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	208302	SHILPA
IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	078340	SUN PHARM
IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	204285	TEVA PHARMS USA
IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	210658	ZYDUS PHARMS

TABLET;ORAL; EQ 400MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GLEEVEC	IMATINIB MESYLATE	EQ 400MG BASE	TABLET;ORAL	Prescription	Yes	AB	021588	NOVARTIS
IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 400MG BASE	TABLET;ORAL	Prescription	No	AB	079179	APOTEX
IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 400MG BASE	TABLET;ORAL	Prescription	No	AB	208429	CHARTWELL RX
IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 400MG BASE	TABLET;ORAL	Prescription	No	AB	206547	DR REDDYS
IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 400MG BASE	TABLET;ORAL	Prescription	No	AB	212773	EUGIA PHARMA
IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 400MG BASE	TABLET;ORAL	Prescription	No	AB	204644	MYLAN
IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 400MG BASE	TABLET;ORAL	Prescription	No	AB	207818	NATCO PHARMA LTD
IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 400MG BASE	TABLET;ORAL	Prescription	No	AB	212135	QILU PHARM HAINAN
IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 400MG BASE	TABLET;ORAL	Prescription	No	AB	208302	SHILPA
IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 400MG BASE	TABLET;ORAL	Prescription	No	AB	078340	SUN PHARM
IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 400MG BASE	TABLET;ORAL	Prescription	No	AB	204285	TEVA PHARMS USA
IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 400MG BASE	TABLET;ORAL	Prescription	No	AB	210658	ZYDUS PHARMS

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