Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214630
Company: BIOCON PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MYCOPHENOLIC ACID MYCOPHENOLIC ACID EQ 180MG BASE TABLET, DELAYED RELEASE;ORAL Prescription AB No No
MYCOPHENOLIC ACID MYCOPHENOLIC ACID EQ 360MG BASE 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
11/29/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

MYCOPHENOLIC ACID

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MYCOPHENOLIC ACID MYCOPHENOLIC ACID EQ 180MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 214630 BIOCON PHARMA

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MYCOPHENOLIC ACID MYCOPHENOLIC ACID EQ 360MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 214630 BIOCON PHARMA

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