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Approved Drug Products containing Esomeprazole Magnesium Dihydrate listed in the FDA Orange Book. Original Data : FDA Website

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01 7DR REDDYS

02 2ETHYPHARM

03 2GRANULES

04 2ACTAVIS LABS FL INC

05 2AJANTA PHARMA LTD

06 2ALKEM LABS LTD

07 3AMNEAL PHARMS NY

08 7ASTRAZENECA

09 2ASTRAZENECA LP

10 1AUROBINDO PHARMA

11 3AUROBINDO PHARMA LTD

12 3CIPLA

13 2CISEN

14 2CSPC OUYI

15 1DEXCEL

16 2DR REDDYS LABS LTD

17 3GLENMARK SPECLT

18 3GRAVITI PHARMS

19 2GUANGZHOU NOVAKEN

20 1GUARDIAN DRUG

21 2HEC PHARM

22 6HETERO LABS LTD III

23 2HORIZON

24 2INDCHEMIE HEALTH

25 2IVAX SUB TEVA PHARMS

26 2LANNETT CO INC

27 1MARKSANS PHARMA

28 5MYLAN

29 1NORVIUM BIOSCIENCE

30 1P AND L

31 1PERRIGO R AND D

32 2PRINSTON INC

33 2SCIEGEN PHARMS INC

34 3SUN PHARM

35 2TORRENT

36 2ZHEJIANG YONGTAI

37 4ZYDUS PHARMS

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

RLD : No

TE Code : AB

ESOMEPRAZOLE MAGNESIUM

Brand Name : ESOMEPRAZOLE MAGNESIUM

Dosage Form : CAPSULE, DELAYED REL PELLETS;ORAL

Dosage Strength : EQ 20MG BASE

Approval Date : 2023-10-18

Application Number : 217427

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Granules India

02

  • 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

ESOMEPRAZOLE MAGNESIUM

Brand Name : ESOMEPRAZOLE MAGNESIUM

Dosage Form : CAPSULE, DELAYED REL PELLETS;ORAL

Dosage Strength : EQ 20MG BASE

Approval Date : 2015-09-25

Application Number : 78279

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEthypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.

RLD : No

TE Code : AB

ESOMEPRAZOLE MAGNESIUM

Brand Name : ESOMEPRAZOLE MAGNESIUM

Dosage Form : CAPSULE, DELAYED REL PELLETS;ORAL

Dosage Strength : EQ 20MG BASE

Approval Date : 2021-03-31

Application Number : 90841

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Ethypharm

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

RLD : No

TE Code : AB

ESOMEPRAZOLE MAGNESIUM

Brand Name : ESOMEPRAZOLE MAGNESIUM

Dosage Form : CAPSULE, DELAYED REL PELLETS;ORAL

Dosage Strength : EQ 40MG BASE

Approval Date : 2023-10-18

Application Number : 217427

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Granules India

05

  • 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

ESOMEPRAZOLE MAGNESIUM

Brand Name : ESOMEPRAZOLE MAGNESIUM

Dosage Form : CAPSULE, DELAYED REL PELLETS;ORAL

Dosage Strength : EQ 40MG BASE

Approval Date : 2015-09-25

Application Number : 78279

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

06

  • 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

ESOMEPRAZOLE MAGNESIUM; NAPROXEN

Brand Name : NAPROXEN AND ESOMEPRAZOLE MAGNESIUM

Dosage Form : TABLET, DELAYED RELEASE;ORAL

Dosage Strength : EQ 20MG BASE;375MG

Approval Date : 2020-02-18

Application Number : 204206

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

07

  • 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

ESOMEPRAZOLE MAGNESIUM; NAPROXEN

Brand Name : NAPROXEN AND ESOMEPRAZOLE MAGNESIUM

Dosage Form : TABLET, DELAYED RELEASE;ORAL

Dosage Strength : EQ 20MG BASE;500MG

Approval Date : 2020-02-18

Application Number : 204206

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

08

  • fda
  • EDQM
  • WHO-GMP

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

RLD : No

TE Code :

ESOMEPRAZOLE MAGNESIUM

Brand Name : ESOMEPRAZOLE MAGNESIUM

Dosage Form : CAPSULE, DELAYED RELEASE;ORAL

Dosage Strength : EQ 20MG BASE

Approval Date : 2024-04-30

Application Number : 207198

RX/OTC/DISCN : OTC

RLD : No

TE Code :

Dr Reddy Company Banner

09

  • fda
  • EDQM
  • WHO-GMP

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

RLD : No

TE Code :

ESOMEPRAZOLE MAGNESIUM

Brand Name : ESOMEPRAZOLE MAGNESIUM

Dosage Form : CAPSULE, DELAYED RELEASE;ORAL

Dosage Strength : EQ 20MG BASE

Approval Date : 2018-05-15

Application Number : 207673

RX/OTC/DISCN : OTC

RLD : No

TE Code :

Dr Reddy Company Banner

10

  • fda
  • EDQM
  • WHO-GMP

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

RLD : No

TE Code :

ESOMEPRAZOLE MAGNESIUM

Brand Name : ESOMEPRAZOLE MAGNESIUM

Dosage Form : TABLET, DELAYED RELEASE;ORAL

Dosage Strength : EQ 20MG BASE

Approval Date : 2020-05-14

Application Number : 211571

RX/OTC/DISCN : OTC

RLD : No

TE Code :

Dr Reddy Company Banner