Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203005
Company: ALKEM LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 200MG/ML SUSPENSION;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
11/14/2014 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
01/11/2019 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

01/11/2019 SUPPL-6 Labeling-Package Insert, Labeling-Proprietary Name Change

Label is not available on this site.

01/11/2019 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

11/06/2015 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/13/2015 SUPPL-1 REMS-Modified

Label is not available on this site.

MYCOPHENOLATE MOFETIL

SUSPENSION;ORAL; 200MG/ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CELLCEPT MYCOPHENOLATE MOFETIL 200MG/ML SUSPENSION;ORAL Prescription Yes AB 050759 ROCHE PALO
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 200MG/ML SUSPENSION;ORAL Prescription No AB 203005 ALKEM LABS LTD
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 200MG/ML SUSPENSION;ORAL Prescription No AB 210370 VISTAPHARM

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