Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 079179
Company: APOTEX INC
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/05/2016 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
08/17/2016 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

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 207495 AMNEAL PHARMS
IMATINIB MESYLATE IMATINIB MESYLATE EQ 100MG BASE TABLET;ORAL Prescription No AB 079179 APOTEX INC
IMATINIB MESYLATE IMATINIB MESYLATE EQ 100MG BASE TABLET;ORAL Prescription No AB 205990 BRECKENRIDGE PHARM
IMATINIB MESYLATE IMATINIB MESYLATE EQ 100MG BASE TABLET;ORAL Prescription No AB 206547 DR REDDYS LABS LTD
IMATINIB MESYLATE IMATINIB MESYLATE EQ 100MG BASE TABLET;ORAL Prescription No AB 204644 MYLAN PHARMS INC
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 208302 SHILPA MEDICARE LTD
IMATINIB MESYLATE IMATINIB MESYLATE EQ 100MG BASE TABLET;ORAL Prescription No AB 078340 SUN PHARMA GLOBAL
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 207586 WEST-WARD PHARMS INT
IMATINIB MESYLATE IMATINIB MESYLATE EQ 100MG BASE TABLET;ORAL Prescription No AB 208429 WOCKHARDT BIO AG

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 207495 AMNEAL PHARMS
IMATINIB MESYLATE IMATINIB MESYLATE EQ 400MG BASE TABLET;ORAL Prescription No AB 079179 APOTEX INC
IMATINIB MESYLATE IMATINIB MESYLATE EQ 400MG BASE TABLET;ORAL Prescription No AB 205990 BRECKENRIDGE PHARM
IMATINIB MESYLATE IMATINIB MESYLATE EQ 400MG BASE TABLET;ORAL Prescription No AB 206547 DR REDDYS LABS LTD
IMATINIB MESYLATE IMATINIB MESYLATE EQ 400MG BASE TABLET;ORAL Prescription No AB 204644 MYLAN PHARMS INC
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 208302 SHILPA MEDICARE LTD
IMATINIB MESYLATE IMATINIB MESYLATE EQ 400MG BASE TABLET;ORAL Prescription No AB 078340 SUN PHARMA GLOBAL
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 207586 WEST-WARD PHARMS INT
IMATINIB MESYLATE IMATINIB MESYLATE EQ 400MG BASE TABLET;ORAL Prescription No AB 208429 WOCKHARDT BIO AG

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