Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078872
Company: PAR PHARM

Products on ANDA 078872

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUVASTATIN SODIUM	FLUVASTATIN SODIUM	80MG	TABLET, EXTENDED RELEASE; ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078872

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/15/2009	ORIG-1	Tentative Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078872s000ltr.pdf