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

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01 3SANOFI AVENTIS US

02 2AET PHARMA

03 2ABHAI LLC

04 2ALEMBIC PHARMS LTD

05 2APOTEX INC

06 2AUROBINDO PHARMA

07 2BARR

08 2HERITAGE

09 2LUPIN LTD

10 2SANDOZ

11 2TEVA PHARMS

12 2WANBANG BIOPHARMS

13 2ZYDUS LIFESCIENCES

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PharmaCompass

01

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AAPS 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

RLD : Yes

TE Code : AB

LEFLUNOMIDE

Brand Name : ARAVA

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 1998-09-10

Application Number : 20905

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Sanofi Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

RLD : No

TE Code : AB

LEFLUNOMIDE

Brand Name : LEFLUNOMIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2021-05-10

Application Number : 213497

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Tiefenbacher Compnay Banner

03

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AAPS 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

RLD : Yes

TE Code : AB

LEFLUNOMIDE

Brand Name : ARAVA

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

Approval Date : 1998-09-10

Application Number : 20905

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Sanofi Company Banner

04

arrow
AAPS 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

RLD : Yes

TE Code :

LEFLUNOMIDE

Brand Name : ARAVA

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG

Approval Date : 1998-09-10

Application Number : 20905

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Sanofi Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

RLD : No

TE Code : AB

LEFLUNOMIDE

Brand Name : LEFLUNOMIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

Approval Date : 2021-05-10

Application Number : 213497

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Tiefenbacher Compnay Banner

06

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

LEFLUNOMIDE

Brand Name : LEFLUNOMIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2005-09-13

Application Number : 77083

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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07

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

LEFLUNOMIDE

Brand Name : LEFLUNOMIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

Approval Date : 2005-09-13

Application Number : 77083

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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08

AAPS 2024
Not Confirmed
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09

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

LEFLUNOMIDE

Brand Name : LEFLUNOMIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2005-09-13

Application Number : 77084

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

blank

10

AAPS 2024
Not Confirmed
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arrow
AAPS 2024
Not Confirmed

LEFLUNOMIDE

Brand Name : LEFLUNOMIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

Approval Date : 2005-09-13

Application Number : 77084

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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