Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090499
Company: APOTEX

• Other Important Information from FDA

• REMS

Products on ANDA 090499

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	500MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090499

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/22/2009	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
10/06/2015	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
11/13/2015	SUPPL-10	REMS-Modified		Label is not available on this site.
10/06/2015	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
09/27/2013	SUPPL-8	Labeling-Package Insert, REMS-Modified		Label is not available on this site.
08/31/2012	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
09/25/2012	SUPPL-4	REMS-Proposal		Label is not available on this site.
04/16/2010	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/15/2010	SUPPL-2	Labeling-Package Insert		Label is not available on this site.