Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 050791
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MYFORTIC MYCOPHENOLIC ACID 180MG TABLET, DELAYED RELEASE;ORAL Prescription AB Yes No
MYFORTIC MYCOPHENOLIC ACID 360MG 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
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-Package Insert, Labeling-Medication Guide 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
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050791s018lbl.pdf
09/27/2013 SUPPL-18 Labeling-Medication Guide 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; 180MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MYCOPHENOLIC ACID MYCOPHENOLIC ACID 180MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 202555 ACCORD HLTHCARE
MYCOPHENOLIC ACID MYCOPHENOLIC ACID 180MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 091558 APOTEX INC
MYCOPHENOLIC ACID MYCOPHENOLIC ACID 180MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 091248 MYLAN PHARMS INC
MYCOPHENOLIC ACID MYCOPHENOLIC ACID 180MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 202720 TEVA PHARMS USA
MYFORTIC MYCOPHENOLIC ACID 180MG TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 050791 NOVARTIS

TABLET, DELAYED RELEASE;ORAL; 360MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MYCOPHENOLIC ACID MYCOPHENOLIC ACID 360MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 202555 ACCORD HLTHCARE
MYCOPHENOLIC ACID MYCOPHENOLIC ACID 360MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 091558 APOTEX INC
MYCOPHENOLIC ACID MYCOPHENOLIC ACID 360MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 091248 MYLAN PHARMS INC
MYCOPHENOLIC ACID MYCOPHENOLIC ACID 360MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 202720 TEVA PHARMS USA
MYFORTIC MYCOPHENOLIC ACID 360MG TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 050791 NOVARTIS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English