Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065521
Company: MYLAN

• Other Important Information from FDA

• REMS

Products on ANDA 065521

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 065521

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/04/2009	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
01/11/2023	SUPPL-32	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/08/2022	SUPPL-30	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/11/2021	SUPPL-28	REMS - MODIFIED - D-N-A		Label is not available on this site.
04/21/2021	SUPPL-26	REMS - MODIFIED - D-N-A		Label is not available on this site.
01/15/2021	SUPPL-24	REMS - MODIFIED - D-N-A		Label is not available on this site.
05/04/2021	SUPPL-23	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/11/2019	SUPPL-20	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/11/2019	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
10/30/2015	SUPPL-14	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/13/2015	SUPPL-13	REMS-Modified		Label is not available on this site.
09/27/2013	SUPPL-10	REMS-Modified, Labeling-Package Insert		Label is not available on this site.
08/09/2012	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
09/25/2012	SUPPL-8	REMS-Proposal		Label is not available on this site.
02/04/2010	SUPPL-4	Labeling-Container/Carton Labels		Label is not available on this site.
01/29/2010	SUPPL-3	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 065521

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