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Approved Drug Products containing DSSTox_CID_3581 listed in the FDA Orange Book. Original Data : FDA Website

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01 5DR REDDYS LABS INC

02 4DR REDDYS LABS SA

03 5ACCORD HLTHCARE

04 4ALKEM LABS LTD

05 4AMNEAL PHARMS CO

06 4ANI PHARMS

07 5AUROBINDO PHARMA

08 4AUROBINDO PHARMA USA

09 5BIOCON PHARMA

10 5CHARTWELL RX

11 4GLENMARK PHARMS LTD

12 5HETERO LABS LTD III

13 4INVAGEN PHARMS

14 5IVAX SUB TEVA PHARMS

15 5LUPIN

16 6MERCK SHARP DOHME

17 5MICRO LABS

18 5NORVIUM BIOSCIENCE

19 9ORGANON

20 5OXFORD PHARMS

21 2SALERNO PHARMS

22 5SUN PHARM INDS LTD

23 4SYNTHON PHARMS

24 5TEVA PHARMS

25 4WATSON LABS INC

26 5WATSON LABS TEVA

27 5ZYDUS PHARMS USA

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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

SIMVASTATIN

Brand Name : SIMVASTATIN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2006-12-20

Application Number : 77752

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

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

SIMVASTATIN

Brand Name : SIMVASTATIN

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

Approval Date : 2006-12-20

Application Number : 77752

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

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

SIMVASTATIN

Brand Name : SIMVASTATIN

Dosage Form : TABLET;ORAL

Dosage Strength : 40MG

Approval Date : 2006-12-20

Application Number : 77752

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

04

  • 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

SIMVASTATIN

Brand Name : SIMVASTATIN

Dosage Form : TABLET;ORAL

Dosage Strength : 80MG

Approval Date : 2006-12-20

Application Number : 77752

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

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

SIMVASTATIN

Brand Name : SIMVASTATIN

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date : 2008-01-23

Application Number : 77752

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

EZETIMIBE; SIMVASTATIN

Brand Name : EZETIMIBE AND SIMVASTATIN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG;10MG

Approval Date : 2017-04-26

Application Number : 200909

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

EZETIMIBE; SIMVASTATIN

Brand Name : EZETIMIBE AND SIMVASTATIN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG;20MG

Approval Date : 2017-04-26

Application Number : 200909

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 : AB

EZETIMIBE; SIMVASTATIN

Brand Name : EZETIMIBE AND SIMVASTATIN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG;40MG

Approval Date : 2017-04-26

Application Number : 200909

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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 : AB

EZETIMIBE; SIMVASTATIN

Brand Name : EZETIMIBE AND SIMVASTATIN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG;80MG

Approval Date : 2017-04-26

Application Number : 200909

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

10

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

SIMVASTATIN

Brand Name : ZOCOR

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date : 1991-12-23

Application Number : 19766

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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