Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211173
Company: CONCORD BIOTECH LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MYCOPHENOLIC ACID MYCOPHENOLIC SODIUM EQ 180MG BASE TABLET, DELAYED RELEASE;ORAL Prescription AB No No
MYCOPHENOLIC ACID MYCOPHENOLIC SODIUM 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
12/13/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/11/2021 SUPPL-7 REMS - MODIFIED - D-N-A

Label is not available on this site.

04/21/2021 SUPPL-6 REMS - MODIFIED - D-N-A

Label is not available on this site.

01/15/2021 SUPPL-4 REMS - MODIFIED - D-N-A

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 SODIUM EQ 180MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 202555 ACCORD HLTHCARE
MYCOPHENOLIC ACID MYCOPHENOLIC SODIUM EQ 180MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 208315 ALKEM LABS LTD
MYCOPHENOLIC ACID MYCOPHENOLIC SODIUM EQ 180MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 214376 AMTA
MYCOPHENOLIC ACID MYCOPHENOLIC SODIUM EQ 180MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 091558 APOTEX INC
MYCOPHENOLIC ACID MYCOPHENOLIC SODIUM EQ 180MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 211173 CONCORD BIOTECH LTD
MYCOPHENOLIC ACID MYCOPHENOLIC SODIUM EQ 180MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 091248 RK PHARMA
MYCOPHENOLIC ACID MYCOPHENOLIC SODIUM EQ 180MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 214289 TWI PHARMS

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 SODIUM EQ 360MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 202555 ACCORD HLTHCARE
MYCOPHENOLIC ACID MYCOPHENOLIC SODIUM EQ 360MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 208315 ALKEM LABS LTD
MYCOPHENOLIC ACID MYCOPHENOLIC SODIUM EQ 360MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 214376 AMTA
MYCOPHENOLIC ACID MYCOPHENOLIC SODIUM EQ 360MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 091558 APOTEX INC
MYCOPHENOLIC ACID MYCOPHENOLIC SODIUM EQ 360MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 211173 CONCORD BIOTECH LTD
MYCOPHENOLIC ACID MYCOPHENOLIC SODIUM EQ 360MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 091248 RK PHARMA
MYCOPHENOLIC ACID MYCOPHENOLIC SODIUM EQ 360MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 214289 TWI PHARMS

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