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

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01 1AMNEAL

02 1BEDFORD LABS

03 1BPI LABS

04 1ENDO OPERATIONS

05 1MEITHEAL

06 1MYLAN LABS LTD

07 1RISING PHARMA

08 1ROCHE PALO

09 1STERISCIENCE SPECLTS

10 1ZYDUS PHARMS

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01

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MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Brand Name : MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 500MG/VIAL

Approval Date : 2021-03-05

Application Number : 211374

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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02

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MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Brand Name : MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Dosage Form : INJECTABLE; INJECTION

Dosage Strength : 500MG

Approval Date :

Application Number : 90311

RX/OTC/DISCN :

RLD :

TE Code :

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03

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MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Brand Name : MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 500MG/VIAL

Approval Date : 2023-06-01

Application Number : 214283

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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04

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MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Brand Name : CELLCEPT

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 500MG/VIAL

Approval Date : 1998-08-12

Application Number : 50758

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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05

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MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Brand Name : MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 500MG/VIAL

Approval Date : 2021-01-15

Application Number : 212130

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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06

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MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Brand Name : MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 500MG/VIAL

Approval Date : 2017-03-31

Application Number : 203859

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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07

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MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Brand Name : MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 500MG/VIAL

Approval Date : 2017-08-31

Application Number : 204473

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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08

ENDO OPERATIONS

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ENDO OPERATIONS

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MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Brand Name : MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 500MG/VIAL

Approval Date : 2016-10-28

Application Number : 203575

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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09

RISING PHARMA

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RISING PHARMA

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MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Brand Name : MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 500MG/VIAL

Approval Date : 2017-02-28

Application Number : 204043

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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10

STERISCIENCE SPECLTS

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STERISCIENCE SPECLTS

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MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Brand Name : MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 500MG/VIAL

Approval Date : 2022-12-23

Application Number : 216390

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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