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

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01 2DR REDDYS

02 1AUCTA

03 1GRANULES

04 1ACCORD HLTHCARE

05 1ALKEM LABS LTD

06 2AMNEAL PHARMS

07 1ANNORA PHARMA

08 2AUROBINDO PHARMA LTD

09 1CHARTWELL RX

10 2DEXCEL

11 1ENDO OPERATIONS

12 1HIKMA

13 1INVAGEN PHARMS

14 2LUNDBECK PHARMS LLC

15 1MSN

16 2PROPEL PHARMA

17 2PYROS PHARMS

18 1SPECGX LLC

19 2TEVA PHARMS USA

20 1UPSHER SMITH LABS

21 2ZYDUS LIFESCIENCES

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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 : AA

VIGABATRIN

Brand Name : VIGABATRIN

Dosage Form : FOR SOLUTION;ORAL

Dosage Strength : 500MG/PACKET

Approval Date : 2018-11-20

Application Number : 211481

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Dr Reddy Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAucta is a global brand that creates better products from proven molecules.

RLD : No

TE Code : AA

VIGABATRIN

Brand Name : VIGADRONE

Dosage Form : FOR SOLUTION;ORAL

Dosage Strength : 500MG/PACKET

Approval Date : 2018-06-21

Application Number : 210196

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Aucta Company Banner

03

  • 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 :

VIGABATRIN

Brand Name : VIGABATRIN

Dosage Form : FOR SOLUTION;ORAL

Dosage Strength : 500MG/PACKET

Approval Date : 2020-04-24

Application Number : 213469

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Granules India

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

VIGABATRIN

Brand Name : VIGABATRIN

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG

Approval Date : 2021-01-29

Application Number : 211539

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Dr Reddy Company Banner

05

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VIGABATRIN

Brand Name : VIGABATRIN

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG

Approval Date : 2022-06-22

Application Number : 210042

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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06

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VIGABATRIN

Brand Name : SABRIL

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG

Approval Date : 2009-08-21

Application Number : 20427

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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07

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VIGABATRIN

Brand Name : SABRIL

Dosage Form : FOR SOLUTION;ORAL

Dosage Strength : 500MG/PACKET

Approval Date : 2009-08-21

Application Number : 22006

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AA

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08

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VIGABATRIN

Brand Name : VIGABATRIN

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG

Approval Date : 2019-01-14

Application Number : 209822

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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09

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VIGABATRIN

Brand Name : VIGABATRIN

Dosage Form : FOR SOLUTION;ORAL

Dosage Strength : 500MG/PACKET

Approval Date : 2018-04-23

Application Number : 209824

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

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10

ENDO OPERATIONS

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ENDO OPERATIONS

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VIGABATRIN

Brand Name : VIGABATRIN

Dosage Form : FOR SOLUTION;ORAL

Dosage Strength : 500MG/PACKET

Approval Date : 2017-04-27

Application Number : 208218

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

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