CELLCEPT از شرکت ROCHE PALO

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

CELLCEPT از شرکت ROCHE PALO

New Drug Application (NDA): 050722

Company: ROCHE PALO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CELLCEPT MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription

AB

Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/03/1995 ORIG-1 Approval

Type 1 – New Molecular Entity

PRIORITY

Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050722Orig1s000rev.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/21/2021 SUPPL-47 REMS – MODIFIED – D-N-A

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050722Orig1s047, 050723Orig1s047, 050758Orig1s044, 050759Orig1s052ltr.pdf

01/15/2021 SUPPL-44 REMS – MODIFIED – D-N-A

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050722Orig1s044, 050723Orig1s044, 050758Orig1s041, 050759Orig1s049ltr.pdf

12/13/2019 SUPPL-40 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050722s040,050723s041,050758s037,050759s045lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050722Orig1s040,050723Orig1s041,050758Orig1s037,050759Orig1s045ltr.pdf

02/27/2019 SUPPL-38 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050722s038,050723s038,050758s035,050759s043lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050722Orig1s038,050723Orig1s038,050758Orig1s035,050759Orig1s043ltr.pdf

12/18/2017 SUPPL-37 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050722s037,050723s037,050758s034,050759s042lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050722Orig1s037, 050723Orig1s037, 050758Orig1s034, 050759Orig1s042ltr.pdf

08/23/2018 SUPPL-35 Labeling-Package Insert, Labeling-Medication Guide

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050722s035,050723s035,050758s033,050759s041lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050722Orig1s035,050723Orig1s035,050758Orig1s033,050759Orig1s041Ltr.pdf

11/13/2015 SUPPL-34 REMS-Modified

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050722Orig1s034,050723Orig1s033,050758Orig1s031,050759Orig1s040ltr.pdf

07/09/2015 SUPPL-33 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050722s033,050723s032,050758s030,050759s038lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050722Orig1s033,050723Orig1s032,050758Orig1s030,050759Orig1s038ltr.pdf

01/23/2014 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

09/27/2013 SUPPL-31 REMS-Proposal

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050722s030s031,050723s029s030,050758s028s029,.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050722Orig1s030,s031,050723Orig1s029,s030,050758Orig1s028,s029,050759Orig1s036,s037ltr.pdf

09/27/2013 SUPPL-30 Labeling, Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050722s030s031,050723s029s030,050758s028s029,.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050722Orig1s030,s031,050723Orig1s029,s030,050758Orig1s028,s029,050759Orig1s036,s037ltr.pdf

06/22/2012 SUPPL-28 Labeling-Medication Guide

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s028,050723s027,050758s026,050759s033lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722s028,050723s027,050758s026,050759s033ltr.pdf

02/14/2013 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

06/08/2012 SUPPL-26 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s026,050723s025,050758s024,050759s031lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722s026,050723s025,050758s024,050759s031ltr.pdf

10/08/2009 SUPPL-24 Labeling-Medication Guide

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s024,050723s023,050758s022,050759s028lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s024,059723s023,050758s022,050759s028ltr.pdf

09/25/2012 SUPPL-22 Labeling, REMS-Proposal

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722Orig1s022,050723Orig1s020,050758Orig1s020,050759Orig1s025ltr.pdf

06/18/2009 SUPPL-21 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s021,050723s019,050758s019,050759s024lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s021,050723s019,050758s019,050759s024ltr.pdf

02/27/2009 SUPPL-20 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s020,050723s018,050758s018,050759s023lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s020,050723s018,050758s018,050759s023ltr.pdf

12/15/2008 SUPPL-19 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050722s19,050723s17,050758s17,050759s22lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050722s019, 050723s017, 050758s017, 050759s022ltr.pdf

05/09/2008 SUPPL-18 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050722s018lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050722s018_050723s015_050758s016_050759s021ltr.pdf

09/21/2007 SUPPL-16 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050722s16,50723s13,50758s14,50759s19lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050722s16,50723s13,50758s14,50759s19ltr.pdf

12/20/2007 SUPPL-15 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050722s015,050723s012,050758s013,050759s018lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050722s015,050723s012,050758s013,050759s018ltr.pdf

10/17/2005 SUPPL-13 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050722s013,050723s010,050758s012,050759s015lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050722s013,050723s010,050758s012,050759s015ltr.pdf

05/31/2002 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/14/2001 SUPPL-9 Manufacturing (CMC)-Packaging

Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50-722s009_CellCept.cfm

02/28/2003 SUPPL-8 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050759s008lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50759slr008,50758slr005,50723slr006,50722slr008ltr.pdf

12/20/2000 SUPPL-7 Efficacy-New Patient Population

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50759S5lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50759S5ltr.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722S007_CellCept.cfm

05/15/2000 SUPPL-6 Manufacturing (CMC)-Control

Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722s006_CellCept.cfm

07/28/2000 SUPPL-5 Efficacy-New Indication

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50722005LBL.PDF

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50759S6LTR.PDF

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722S005_CellCept.cfm

07/27/2000 SUPPL-4 Labeling

Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722s004_50-723s003_50-758s003_50-759s004_CellCept.cfm

04/13/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/11/1998 SUPPL-2 Efficacy-New Indication

Label is not available on this site.

06/12/1997 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/13/2019 SUPPL-40

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050722s040,050723s041,050758s037,050759s045lbl.pdf
02/27/2019 SUPPL-38

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050722s038,050723s038,050758s035,050759s043lbl.pdf
08/23/2018 SUPPL-35

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050722s035,050723s035,050758s033,050759s041lbl.pdf
08/23/2018 SUPPL-35

Labeling-Medication Guide

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050722s035,050723s035,050758s033,050759s041lbl.pdf
12/18/2017 SUPPL-37

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050722s037,050723s037,050758s034,050759s042lbl.pdf
07/09/2015 SUPPL-33

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050722s033,050723s032,050758s030,050759s038lbl.pdf
09/27/2013 SUPPL-31

REMS-Proposal

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050722s030s031,050723s029s030,050758s028s029,.pdf
09/27/2013 SUPPL-30

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050722s030s031,050723s029s030,050758s028s029,.pdf
09/27/2013 SUPPL-30

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050722s030s031,050723s029s030,050758s028s029,.pdf
06/22/2012 SUPPL-28

Labeling-Medication Guide

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s028,050723s027,050758s026,050759s033lbl.pdf
06/08/2012 SUPPL-26

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s026,050723s025,050758s024,050759s031lbl.pdf
10/08/2009 SUPPL-24

Labeling-Medication Guide

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s024,050723s023,050758s022,050759s028lbl.pdf
06/18/2009 SUPPL-21

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s021,050723s019,050758s019,050759s024lbl.pdf
02/27/2009 SUPPL-20

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s020,050723s018,050758s018,050759s023lbl.pdf
12/15/2008 SUPPL-19

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050722s19,050723s17,050758s17,050759s22lbl.pdf
05/09/2008 SUPPL-18

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050722s018lbl.pdf
12/20/2007 SUPPL-15

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050722s015,050723s012,050758s013,050759s018lbl.pdf
09/21/2007 SUPPL-16

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050722s16,50723s13,50758s14,50759s19lbl.pdf
10/17/2005 SUPPL-13

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050722s013,050723s010,050758s012,050759s015lbl.pdf
02/28/2003 SUPPL-8

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050759s008lbl.pdf
12/20/2000 SUPPL-7

Efficacy-New Patient Population

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50759S5lbl.pdf
07/28/2000 SUPPL-5

Efficacy-New Indication

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50722005LBL.PDF

CELLCEPT

CAPSULE;ORAL; 250MG

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CELLCEPT MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription Yes AB 050722 ROCHE PALO
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription No AB 090253 ACCORD HLTHCARE
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription No AB 200197 ALKEM LABS LTD
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription No AB 210181 CONCORD BIOTECH LTD
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription No AB 065410 HIKMA
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription No AB 065520 MYLAN
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription No AB 065379 SANDOZ
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription No AB 090055 STRIDES PHARMA
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription No AB 065491 TEVA PHARMS
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription No AB 204077 ZHEJIANG HISUN PHARM
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