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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090606
Company: AMNEAL
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
07/16/2010 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/11/2021 SUPPL-11 REMS - MODIFIED - D-N-A

Label is not available on this site.

04/21/2021 SUPPL-10 REMS - MODIFIED - D-N-A

Label is not available on this site.

01/15/2021 SUPPL-9 REMS - MODIFIED - D-N-A

Label is not available on this site.

07/27/2016 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

11/13/2015 SUPPL-7 REMS-Modified

Label is not available on this site.

09/27/2013 SUPPL-6 REMS-Modified

Label is not available on this site.

08/01/2012 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/25/2012 SUPPL-3 REMS-Proposal

Label is not available on this site.

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 090606 AMNEAL
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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