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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065410
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Discontinued None 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/2008/065410s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/065410s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/29/2026 SUPPL-25 REMS - MODIFIED - D-N-A

Label is not available on this site.
08/13/2024 SUPPL-23 REMS - MODIFIED - D-N-A

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.
02/07/2024 SUPPL-20 Labeling-Package Insert

Label is not available on this site.
08/11/2021 SUPPL-19 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-14 REMS - MODIFIED - D-N-A

Label is not available on this site.
06/16/2020 SUPPL-13 Labeling-Package Insert

Label is not available on this site.
11/27/2019 SUPPL-12 Labeling-Package Insert

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

Label is not available on this site.
11/13/2015 SUPPL-9 REMS-Modified

Label is not available on this site.
09/27/2013 SUPPL-8 REMS-Proposal

Label is not available on this site.
09/25/2012 SUPPL-7 REMS-Proposal

Label is not available on this site.
07/25/2012 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
09/12/2014 SUPPL-5 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/2008/065410s000lbl.pdf
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