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

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01 4STRIDES PHARMA

02 2ACCORD HLTHCARE

03 3ALKEM LABS LTD

04 2AMNEAL

05 1APOTEX

06 1APOTEX CORP

07 1AUROBINDO PHARMA

08 1AUROBINDO PHARMA LTD

09 1AZURITY

10 2CONCORD BIOTECH LTD

11 2DR REDDYS LABS LTD

12 1HETERO LABS LTD V

13 2HIKMA

14 2JUBILANT CADISTA

15 1LANNETT CO INC

16 2MYLAN

17 3ROCHE PALO

18 2SANDOZ

19 2TEVA PHARMS

20 1TEVA PHARMS USA

21 1VISTAPHARM

22 2ZHEJIANG HISUN PHARM

23 2ZYDUS PHARMS USA INC

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

RLD : No

TE Code : AB

MYCOPHENOLATE MOFETIL

Brand Name : MYCOPHENOLATE MOFETIL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 250MG

Approval Date : 2010-06-10

Application Number : 90055

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

RLD : No

TE Code :

MYCOPHENOLATE MOFETIL

Brand Name : MYCOPHENOLATE MOFETIL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 250MG

Approval Date : 2009-12-22

Application Number : 90111

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Strides Pharma Science

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

RLD : No

TE Code : AB

MYCOPHENOLATE MOFETIL

Brand Name : MYCOPHENOLATE MOFETIL

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG

Approval Date : 2010-06-10

Application Number : 90456

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

RLD : No

TE Code : AB

MYCOPHENOLATE MOFETIL

Brand Name : MYCOPHENOLATE MOFETIL

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 200MG/ML

Approval Date : 2023-08-29

Application Number : 212634

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

05

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

MYCOPHENOLATE MOFETIL

Brand Name : CELLCEPT

Dosage Form : CAPSULE;ORAL

Dosage Strength : 250MG

Approval Date : 1995-05-03

Application Number : 50722

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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06

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

MYCOPHENOLATE MOFETIL

Brand Name : CELLCEPT

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG

Approval Date : 1997-06-19

Application Number : 50723

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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07

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

MYCOPHENOLATE MOFETIL

Brand Name : CELLCEPT

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 200MG/ML

Approval Date : 1998-10-01

Application Number : 50759

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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08

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

MYCOPHENOLATE MOFETIL

Brand Name : MYCOPHENOLATE MOFETIL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 250MG

Approval Date : 2008-07-29

Application Number : 65410

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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09

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

MYCOPHENOLATE MOFETIL

Brand Name : MYCOPHENOLATE MOFETIL

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG

Approval Date : 2008-07-29

Application Number : 65413

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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10

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

MYCOPHENOLATE MOFETIL

Brand Name : MYCOPHENOLATE MOFETIL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 250MG

Approval Date : 2008-10-15

Application Number : 65379

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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