Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090868
Company: MYLAN PHARMS INC

• Other Important Information from FDA

Products on ANDA 090868

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SIMVASTATIN	SIMVASTATIN	5MG	TABLET;ORAL	Discontinued	None	No	No
SIMVASTATIN	SIMVASTATIN	10MG	TABLET;ORAL	Discontinued	None	No	No
SIMVASTATIN	SIMVASTATIN	20MG	TABLET;ORAL	Discontinued	None	No	No
SIMVASTATIN	SIMVASTATIN	40MG	TABLET;ORAL	Discontinued	None	No	No
SIMVASTATIN	SIMVASTATIN	80MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090868

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/08/2010	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
11/14/2016	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
05/01/2012	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
01/11/2012	SUPPL-3	Labeling-Package Insert		Label is not available on this site.