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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212773
Company: EUGIA PHARMA

Products on ANDA 212773

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 212773

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/23/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/31/2023	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
01/31/2023	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
01/31/2023	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
01/31/2023	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 212773

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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