Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050791
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MYFORTIC | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | Yes | No |
| MYFORTIC | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 02/27/2004 | ORIG-1 | Approval | Type 2 - New Active Ingredient | STANDARD |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50791ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/50-791_Myfortic.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/11/2021 | SUPPL-36 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050791Orig1s036ltr.pdf |
| 03/15/2022 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050791s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050791Orig1s035ltr.pdf | |
| 04/21/2021 | SUPPL-34 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050791Orig1s034ltr.pdf |
| 01/15/2021 | SUPPL-33 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050791Orig1s033ltr.pdf |
| 11/03/2020 | SUPPL-32 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050791Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050791Orig1s032ltr.pdf | |
| 04/28/2020 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050791s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050791Orig1s030ltr.pdf | |
| 10/27/2015 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050791s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050791Orig1s024ltr.pdf | |
| 12/23/2015 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/13/2015 | SUPPL-22 | REMS |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050791Orig1s022ltr.pdf |
| 08/04/2015 | SUPPL-21 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050791Orig1s021ltr.pdf |
| 09/27/2013 | SUPPL-19 | REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050791s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050791Orig1s018,s019ltr.pdf | |
| 09/27/2013 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050791s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050791Orig1s018,s019ltr.pdf | |
| 05/01/2013 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/2013 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/22/2012 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050791s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050791s014ltr.pdf | |
| 05/01/2013 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050791s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050791Orig1s012ltr_corrected.pdf | |
| 10/27/2010 | SUPPL-11 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050791s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050791s011ltr.pdf | |
| 10/08/2009 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050791s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050791s008ltr.pdf | |
| 07/10/2009 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050791s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050791s007ltr.pdf | |
| 03/27/2009 | SUPPL-6 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050791s006ltr.pdf |
| 09/25/2012 | SUPPL-5 | Labeling, REMS-Proposal |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050791Orig1s005ltr.pdf |
| 12/15/2008 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050791s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050791s004ltr.pdf | |
| 05/09/2008 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050791s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050791s002ltr.pdf | |
| 11/02/2007 | SUPPL-1 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050791s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050791s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/15/2022 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050791s035lbl.pdf | |
| 11/03/2020 | SUPPL-32 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050791Orig1s032lbl.pdf |
| 04/28/2020 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050791s030lbl.pdf | |
| 10/27/2015 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050791s024lbl.pdf | |
| 09/27/2013 | SUPPL-19 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050791s019lbl.pdf | |
| 09/27/2013 | SUPPL-18 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050791s018lbl.pdf | |
| 09/27/2013 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050791s018lbl.pdf | |
| 05/01/2013 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050791s012lbl.pdf | |
| 06/22/2012 | SUPPL-14 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050791s014lbl.pdf | |
| 06/22/2012 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050791s014lbl.pdf | |
| 10/27/2010 | SUPPL-11 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050791s011lbl.pdf | |
| 10/08/2009 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050791s008lbl.pdf | |
| 07/10/2009 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050791s007lbl.pdf | |
| 12/15/2008 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050791s004lbl.pdf | |
| 05/09/2008 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050791s002lbl.pdf | |
| 11/02/2007 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050791s001lbl.pdf |
MYFORTIC
TABLET, DELAYED RELEASE;ORAL; EQ 180MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 202555 | ACCORD HLTHCARE |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 208315 | ALKEM LABS LTD |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 214376 | AMTA |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 091558 | APOTEX INC |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 214630 | BIOCON PHARMA |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 211173 | CONCORD BIOTECH LTD |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 091248 | RK PHARMA |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 214289 | TWI PHARMS |
| MYFORTIC | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 050791 | NOVARTIS |
TABLET, DELAYED RELEASE;ORAL; EQ 360MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 202555 | ACCORD HLTHCARE |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 208315 | ALKEM LABS LTD |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 214376 | AMTA |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 091558 | APOTEX INC |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 214630 | BIOCON PHARMA |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 211173 | CONCORD BIOTECH LTD |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 091248 | RK PHARMA |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 214289 | TWI PHARMS |
| MYFORTIC | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 050791 | NOVARTIS |