Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050758
Company: ROCHE PALO
Company: ROCHE PALO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CELLCEPT | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 08/12/1998 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/505758.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/13/2024 | SUPPL-51 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/050722Orig1s053;050723Orig1s053;050758Orig1s051;050759Orig1s059ltr.pdf |
| 06/06/2022 | SUPPL-49 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050722s049s051,050723s049s051,050758s047s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050722Orig1s049,s051;050723Orig1s049,s051;050785Orig1s047,s049;050759Orig1s054,s056ltr.pdf | |
| 08/10/2022 | SUPPL-48 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050722s050,050723s050,050758s048,050759s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050722Orig1s050; 050723Orig1s050; 050758Orig1s048; 050759Orig1s055ltr.pdf | |
| 06/06/2022 | SUPPL-47 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050722s049s051,050723s049s051,050758s047s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050722Orig1s049,s051;050723Orig1s049,s051;050785Orig1s047,s049;050759Orig1s054,s056ltr.pdf | |
| 08/11/2021 | SUPPL-45 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050722Orig1s048,050723Orig1s048,050758Orig1s045,050759Orig1s053ltr.pdf |
| 04/21/2021 | SUPPL-44 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050722Orig1s047, 050723Orig1s047, 050758Orig1s044, 050759Orig1s052ltr.pdf |
| 10/22/2021 | SUPPL-43 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050722s045s046,050723s045s046,050758s042s043,050759s050s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050722Orig1s045, s046; 050723Orig1s045, s046; 050758Orig1s042, s043; 050759Orig1s050, s051ltr.pdf | |
| 10/22/2021 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050722s045s046,050723s045s046,050758s042s043,050759s050s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050722Orig1s045, s046; 050723Orig1s045, s046; 050758Orig1s042, s043; 050759Orig1s050, s051ltr.pdf | |
| 01/15/2021 | SUPPL-41 | 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-37 | Labeling-Container/Carton Labels, 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-35 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050722s038,050723s038,050758s035,050759s043lbl.pdf | |
| 12/18/2017 | SUPPL-34 | 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-33 | Labeling-Medication Guide, Labeling-Package Insert |
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 | |
| 05/26/2016 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/13/2015 | SUPPL-31 | 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-30 | 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 | |
| 09/27/2013 | SUPPL-29 | 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-28 | 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-26 | 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-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/08/2012 | SUPPL-24 | 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-22 | 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-20 | REMS-Proposal, Labeling |
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-19 | 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-18 | 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-17 | 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-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050758s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050722s018_050723s015_050758s016_050759s021ltr.pdf | |
| 09/21/2007 | SUPPL-14 | 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-13 | 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-12 | 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 | |
| 04/12/2005 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050758s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050758s010ltr.pdf | |
| 12/17/2002 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/27/2002 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/28/2003 | SUPPL-5 | 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 | |
| 07/28/2000 | SUPPL-4 | 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-3 | 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 |
| 06/16/2000 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/20/2000 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/10/2022 | SUPPL-48 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050722s050,050723s050,050758s048,050759s055lbl.pdf | |
| 08/10/2022 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050722s050,050723s050,050758s048,050759s055lbl.pdf | |
| 06/06/2022 | SUPPL-49 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050722s049s051,050723s049s051,050758s047s049lbl.pdf | |
| 06/06/2022 | SUPPL-47 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050722s049s051,050723s049s051,050758s047s049lbl.pdf | |
| 10/22/2021 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050722s045s046,050723s045s046,050758s042s043,050759s050s051lbl.pdf | |
| 10/22/2021 | SUPPL-43 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050722s045s046,050723s045s046,050758s042s043,050759s050s051lbl.pdf | |
| 10/22/2021 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050722s045s046,050723s045s046,050758s042s043,050759s050s051lbl.pdf | |
| 12/13/2019 | SUPPL-37 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050722s040,050723s041,050758s037,050759s045lbl.pdf | |
| 12/13/2019 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050722s040,050723s041,050758s037,050759s045lbl.pdf | |
| 02/27/2019 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050722s038,050723s038,050758s035,050759s043lbl.pdf | |
| 08/23/2018 | SUPPL-33 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050722s035,050723s035,050758s033,050759s041lbl.pdf | |
| 08/23/2018 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050722s035,050723s035,050758s033,050759s041lbl.pdf | |
| 12/18/2017 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050722s037,050723s037,050758s034,050759s042lbl.pdf | |
| 07/09/2015 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050722s033,050723s032,050758s030,050759s038lbl.pdf | |
| 09/27/2013 | SUPPL-29 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050722s030s031,050723s029s030,050758s028s029,.pdf | |
| 09/27/2013 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050722s030s031,050723s029s030,050758s028s029,.pdf | |
| 09/27/2013 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050722s030s031,050723s029s030,050758s028s029,.pdf | |
| 06/22/2012 | SUPPL-26 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s028,050723s027,050758s026,050759s033lbl.pdf | |
| 06/08/2012 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s026,050723s025,050758s024,050759s031lbl.pdf | |
| 10/08/2009 | SUPPL-22 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s024,050723s023,050758s022,050759s028lbl.pdf | |
| 06/18/2009 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s021,050723s019,050758s019,050759s024lbl.pdf | |
| 02/27/2009 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s020,050723s018,050758s018,050759s023lbl.pdf | |
| 12/15/2008 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050722s19,050723s17,050758s17,050759s22lbl.pdf | |
| 05/09/2008 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050758s016lbl.pdf | |
| 12/20/2007 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050722s015,050723s012,050758s013,050759s018lbl.pdf | |
| 09/21/2007 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050722s16,50723s13,50758s14,50759s19lbl.pdf | |
| 10/17/2005 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050722s013,050723s010,050758s012,050759s015lbl.pdf | |
| 04/12/2005 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050758s010lbl.pdf | |
| 02/28/2003 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050759s008lbl.pdf | |
| 07/28/2000 | SUPPL-4 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50722005LBL.PDF |
CELLCEPT
INJECTABLE;INJECTION; 500MG/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CELLCEPT | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050758 | ROCHE PALO |
| MYCOPHENOLATE MOFETIL HYDROCHLORIDE | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 214283 | BPI LABS |
| MYCOPHENOLATE MOFETIL HYDROCHLORIDE | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203575 | ENDO OPERATIONS |
| MYCOPHENOLATE MOFETIL HYDROCHLORIDE | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 212130 | MEITHEAL |
| MYCOPHENOLATE MOFETIL HYDROCHLORIDE | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203859 | MYLAN LABS LTD |
| MYCOPHENOLATE MOFETIL HYDROCHLORIDE | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204043 | RISING |
| MYCOPHENOLATE MOFETIL HYDROCHLORIDE | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 216390 | STERISCIENCE SPECLTS |
| MYCOPHENOLATE MOFETIL HYDROCHLORIDE | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204473 | ZYDUS PHARMS |