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MYCOPHENOLATE MOFETIL

ANDA

MYCOPHENOLATE MOFETIL | A065520 | MYLAN PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

API Supply Chain19 active DMFs13 inactive

16 active API suppliers hold Drug Master Files for this ingredient.

BIOCON LTDMYCOPHENOLATE MOFETIL

DMF 164062003

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDMYCOPHENOLATE MOFETIL USP

DMF 184942005

CONCORD BIOTECH LTDMYCOPHENOLATE MOFETIL USP

DMF 192312006

TAPI NL BVMYCOPHENOLATE MOFETIL DRUG SUBSTANCE

DMF 200722006

SHANDONG NEW TIME PHARMACEUTICAL CO LTDMYCOPHENOLATE MOFETIL

DMF 206552007

EXCELLA GMBH AND CO KGMYCOPHENOLATE MOFETIL SIEVED

DMF 210792007

FORMOSA LABORATORIES INCMYCOPHENOLATE MOFETIL

DMF 220462008

LEK PHARMACEUTICALS DDMYCOPHENOLATE MOFETIL (PROCESS B), USP

DMF 253232011

EMCURE PHARMACEUTICALS LTDMYCOPHENOLATE MOFETIL USP

DMF 257442012

HISUN PHARMACEUTICAL HANGZHOU CO LTDMYCOPHENOLATE MOFETIL USP

DMF 264052012

CONCORD BIOTECH LTDMYCOPHENOLATE MOFETIL USP (BY AZEOTROPIC DISTILLATION)

DMF 295532015

TAPI NL BVMYCOPHENOLATE MOFETIL ID: 744010

DMF 322392021

SOLARA ACTIVE PHARMA SCIENCES LTDMYCOPHENOLATE MOFETIL USP

DMF 330212018

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDMYCOPHENOLATE MOFETIL USP (PROCESS B)

DMF 333332018

WUXI FORTUNE PHARMACEUTICAL CO LTDMYCOPHENOLATE MOFETIL

DMF 339342019

CHONGQING DAXIN PHARMACEUTICAL CO LTDMYCOPHENOLATE MOFETIL

DMF 364492021

JOYANG LABORATORIESMYCOPHENOLATE MOFETIL

DMF 409782025

RAKSHIT PHARMACEUTICALS LTDMYCOPHENOLATE MOFETIL

DMF 422572025

DASAMI LAB PRIVATE LTDMYCOPHENOLATE MOFETIL USP

DMF 426822025

LEK PHARMACEUTICALS DDInactiveMYCOPHENOLATE MOFETIL

DMF 189362005

IVAX PHARMACEUTICALS SROInactiveMYCOPHENOLATE MOFETIL USP

DMF 189892005

CIPLA LTDInactiveMYCOPHENOLATE MOFETIL BP/PH. EUR.

DMF 206792007

EXCELLA GMBHInactiveMYCOPHENOLATE MOFETIL

DMF 209482007

APOTEX PHARMACHEM INDIA PVT LTDInactiveMYCOPHENOLATE MOFETIL USP

DMF 212272008

DSM ANTI INFECTIVES BVInactiveMYCOPHENOLATE MOFETIL

DMF 212322008

SHANGHAI YOUNGGREEN BIOTECH CO LTDInactiveMYCOPHENOLATE MOFETIL (NON-STERILE ACTIVE INGREDIENT)

DMF 214232008

WUXI FORTUNE PHARMACEUTICAL CO LTDInactiveMYCOPHENOLATE MOFETIL

DMF 227862009

HAUDONG MEDICINE CO LTDInactiveMYCOPHENOLATE MOFETIL

DMF 229772009

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveMYCOPHENOLATE MOFETIL USP

DMF 253362011

APOTEX PHARMACHEM INDIA PVT LTDInactiveMYCOPHENOLATE MOFETIL USP

DMF 257462012

RPG LIFE SCIENCES LTDInactiveMYCOPHENOLATE MOFETIL USP

DMF 265782013

LIVZON NEW NORTH RIVER PHARMACEUTICAL CO LTDInactiveMYCOPHENOLATE MOFETIL NON-STERILE, BULK FORM

DMF 302462016

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 250MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: May 4, 2009

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDtype7/1/2026

Mylan's MYCOPHENOLATE MOFETIL (mycophenolate mofetil) NDA 065520 transitioned from prescription to discontinued status.

Old: RX

New: DISCN

MODIFIEDTE Code7/1/2026

Mylan's mycophenolate mofetil (MYCOPHENOLATE MOFETIL) therapeutic equivalence code changed from AB to a different rating.

Old: AB