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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204285
Company: TEVA PHARMS USA

Products on ANDA 204285

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 204285

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/04/2016	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/20/2025	SUPPL-18	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
01/09/2020	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
01/09/2020	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
01/09/2020	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
01/09/2020	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
01/09/2020	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
08/17/2016	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204285

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	212975	HETERO LABS LTD V
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	212975	HETERO LABS LTD V
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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