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 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/2008/065410s000lbl.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
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

MYCOPHENOLATE MOFETIL

CAPSULE;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CELLCEPT MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription Yes AB 050722 ROCHE PALO
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription No AB 090253 ACCORD HLTHCARE
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription No AB 200197 ALKEM LABS LTD
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription No AB 210181 CONCORD BIOTECH LTD
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription No AB 065410 HIKMA
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription No AB 065520 MYLAN
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription No AB 065379 SANDOZ
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription No AB 090055 STRIDES PHARMA
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription No AB 065491 TEVA PHARMS
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription No AB 090111 VINTAGE PHARMS LLC
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription No AB 204077 ZHEJIANG HISUN PHARM

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