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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065413
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 500MG TABLET;ORAL Prescription AB No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/29/2008 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/065413s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/065413s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/07/2024 SUPPL-23 Labeling-Package Insert

Label is not available on this site.
02/07/2024 SUPPL-22 Labeling-Package Insert

Label is not available on this site.
02/07/2024 SUPPL-21 Labeling-Package Insert

Label is not available on this site.
08/11/2021 SUPPL-20 REMS - MODIFIED - D-N-A

Label is not available on this site.
04/21/2021 SUPPL-18 REMS - MODIFIED - D-N-A

Label is not available on this site.
05/17/2021 SUPPL-17 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
01/15/2021 SUPPL-15 REMS - MODIFIED - D-N-A

Label is not available on this site.
06/16/2020 SUPPL-14 Labeling-Package Insert

Label is not available on this site.
11/27/2019 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
10/30/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.
11/13/2015 SUPPL-10 REMS-Modified

Label is not available on this site.
09/27/2013 SUPPL-9 Labeling-Package Insert, REMS-Modified, Labeling-Medication Guide

Label is not available on this site.
09/25/2012 SUPPL-8 REMS-Proposal

Label is not available on this site.
07/25/2012 SUPPL-7 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
09/12/2014 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
02/02/2010 SUPPL-4 Labeling-Package Insert

Label is not available on this site.
09/09/2009 SUPPL-3 Labeling

Label is not available on this site.
02/20/2009 SUPPL-2 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/29/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/065413s000lbl.pdf

MYCOPHENOLATE MOFETIL

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CELLCEPT MYCOPHENOLATE MOFETIL 500MG TABLET;ORAL Prescription Yes AB 050723 ROCHE PALO
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 500MG TABLET;ORAL Prescription No AB 065416 ACCORD HLTHCARE
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 500MG TABLET;ORAL Prescription No AB 091249 ALKEM LABS LTD
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 500MG TABLET;ORAL Prescription No AB 217937 AUROBINDO PHARMA
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 500MG TABLET;ORAL Prescription No AB 212087 CONCORD BIOTECH LTD
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 500MG TABLET;ORAL Prescription No AB 065413 HIKMA
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 500MG TABLET;ORAL Prescription No AB 065521 MYLAN
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 500MG TABLET;ORAL Prescription No AB 065451 SANDOZ
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 500MG TABLET;ORAL Prescription No AB 090456 STRIDES PHARMA
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 500MG TABLET;ORAL Prescription No AB 204076 ZHEJIANG HISUN PHARM
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