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Approved Drug Products containing Imatinib Mesilate listed in the FDA Orange Book. Original Data : FDA Website

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01 2DR REDDYS

02 2BRECKENRIDGE

03 2AMNEAL PHARMS

04 2APOTEX

05 2CHARTWELL RX

06 2EUGIA PHARMA

07 2HIKMA

08 2MYLAN

09 2NATCO PHARMA LTD

10 4NOVARTIS

11 2QILU PHARM HAINAN

12 2SHILPA

13 2SUN PHARM

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15 2ZYDUS PHARMS

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code : AB

IMATINIB MESYLATE

Brand Name : IMATINIB MESYLATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 100MG BASE

Approval Date : 2018-08-13

Application Number : 206547

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

02

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Discovery on Target
Not Confirmed

IMATINIB MESYLATE

Brand Name : IMATINIB MESYLATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 100MG BASE

Approval Date : 2019-02-08

Application Number : 205990

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Breckenridge Pharmaceutical

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code : AB

IMATINIB MESYLATE

Brand Name : IMATINIB MESYLATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 400MG BASE

Approval Date : 2018-08-13

Application Number : 206547

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

04

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Discovery on Target
Not Confirmed

IMATINIB MESYLATE

Brand Name : IMATINIB MESYLATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 400MG BASE

Approval Date : 2019-02-08

Application Number : 205990

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Breckenridge Pharmaceutical

05

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

IMATINIB MESYLATE

Brand Name : GLEEVEC

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2001-05-10

Application Number : 21335

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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06

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

IMATINIB MESYLATE

Brand Name : GLEEVEC

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2001-05-10

Application Number : 21335

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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07

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

IMATINIB MESYLATE

Brand Name : GLEEVEC

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 100MG BASE

Approval Date : 2003-04-18

Application Number : 21588

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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08

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

IMATINIB MESYLATE

Brand Name : GLEEVEC

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 400MG BASE

Approval Date : 2003-04-18

Application Number : 21588

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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09

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

IMATINIB MESYLATE

Brand Name : IMATINIB MESYLATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 100MG BASE

Approval Date : 2015-12-03

Application Number : 78340

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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10

Discovery on Target
Not Confirmed
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arrow
Discovery on Target
Not Confirmed

IMATINIB MESYLATE

Brand Name : IMATINIB MESYLATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 400MG BASE

Approval Date : 2015-12-03

Application Number : 78340

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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