Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077520
Company: SUN PHARM INDUSTRIES

Products on ANDA 077520

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077520

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/14/2006	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
08/04/2017	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
11/02/2014	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
12/29/2012	SUPPL-9	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
05/01/2012	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
10/05/2007	SUPPL-4	Labeling		Label is not available on this site.