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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210658
Company: ZYDUS PHARMS
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
04/08/2020 ORIG-1 Approval STANDARD

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 079179 APOTEX
IMATINIB MESYLATE IMATINIB MESYLATE EQ 100MG BASE TABLET;ORAL Prescription No AB 205990 BRECKENRIDGE
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 207586 HIKMA
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 208429 WOCKHARDT BIO AG
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 205990 BRECKENRIDGE
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 207586 HIKMA
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 208429 WOCKHARDT BIO AG
IMATINIB MESYLATE IMATINIB MESYLATE EQ 400MG BASE TABLET;ORAL Prescription No AB 210658 ZYDUS PHARMS
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