Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202555
Company: ACCORD HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MYCOPHENOLIC ACID MYCOPHENOLIC ACID 180MG TABLET, DELAYED RELEASE;ORAL Prescription AB No No
MYCOPHENOLIC ACID MYCOPHENOLIC ACID 360MG TABLET, DELAYED RELEASE;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
08/23/2017 ORIG-1 Approval

Label is not available on this site.

MYCOPHENOLIC ACID

TABLET, DELAYED RELEASE;ORAL; 180MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MYCOPHENOLIC ACID MYCOPHENOLIC ACID 180MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 202555 ACCORD HLTHCARE
MYCOPHENOLIC ACID MYCOPHENOLIC ACID 180MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 091558 APOTEX INC
MYCOPHENOLIC ACID MYCOPHENOLIC ACID 180MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 091248 MYLAN PHARMS INC
MYCOPHENOLIC ACID MYCOPHENOLIC ACID 180MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 202720 TEVA PHARMS USA
MYFORTIC MYCOPHENOLIC ACID 180MG TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 050791 NOVARTIS

TABLET, DELAYED RELEASE;ORAL; 360MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MYCOPHENOLIC ACID MYCOPHENOLIC ACID 360MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 202555 ACCORD HLTHCARE
MYCOPHENOLIC ACID MYCOPHENOLIC ACID 360MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 091558 APOTEX INC
MYCOPHENOLIC ACID MYCOPHENOLIC ACID 360MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 091248 MYLAN PHARMS INC
MYCOPHENOLIC ACID MYCOPHENOLIC ACID 360MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 202720 TEVA PHARMS USA
MYFORTIC MYCOPHENOLIC ACID 360MG TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 050791 NOVARTIS

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