An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 212087
Company: CONCORD BIOTECH LTD

REMS

Products on ANDA 212087

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	500MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212087

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/31/2020	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
11/16/2022	SUPPL-9	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/11/2021	SUPPL-4	REMS - MODIFIED - D-N-A		Label is not available on this site.
04/21/2021	SUPPL-3	REMS - MODIFIED - D-N-A		Label is not available on this site.
01/15/2021	SUPPL-2	REMS - MODIFIED - D-N-A		Label is not available on this site.

Therapeutic Equivalents for ANDA 212087

MYCOPHENOLATE MOFETIL

TABLET;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CELLCEPT	MYCOPHENOLATE MOFETIL	500MG	TABLET;ORAL	Prescription	Yes	AB	050723	ROCHE PALO
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	500MG	TABLET;ORAL	Prescription	No	AB	065416	ACCORD HLTHCARE
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	500MG	TABLET;ORAL	Prescription	No	AB	091249	ALKEM LABS LTD
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	500MG	TABLET;ORAL	Prescription	No	AB	217937	AUROBINDO PHARMA
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	500MG	TABLET;ORAL	Prescription	No	AB	212087	CONCORD BIOTECH LTD
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	500MG	TABLET;ORAL	Prescription	No	AB	065413	HIKMA
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	500MG	TABLET;ORAL	Prescription	No	AB	065521	MYLAN
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	500MG	TABLET;ORAL	Prescription	No	AB	065451	SANDOZ
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	500MG	TABLET;ORAL	Prescription	No	AB	090456	STRIDES PHARMA
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	500MG	TABLET;ORAL	Prescription	No	AB	204076	ZHEJIANG HISUN PHARM

Top