Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065520
Company: MYLAN
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
05/04/2009 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
09/11/2019 SUPPL-22 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/11/2019 SUPPL-20 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/30/2015 SUPPL-17 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/13/2015 SUPPL-16 REMS-Modified

Label is not available on this site.

09/27/2013 SUPPL-13 Labeling-Package Insert, REMS-Modified

Label is not available on this site.

08/09/2012 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

09/25/2012 SUPPL-9 REMS-Proposal

Label is not available on this site.

02/04/2010 SUPPL-4 Labeling-Container/Carton Labels

Label is not available on this site.

01/29/2010 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

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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