Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076052
Company: IVAX SUB TEVA PHARMS

• Other Important Information from FDA

Products on ANDA 076052

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 076052

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/23/2006	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076052s000LTR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/15/2025	SUPPL-49	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
07/31/2023	SUPPL-48	Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
07/31/2023	SUPPL-44	Labeling-Package Insert		Label is not available on this site.
12/16/2015	SUPPL-40	Labeling-Package Insert		Label is not available on this site.
11/05/2014	SUPPL-39	Labeling-Package Insert		Label is not available on this site.
11/05/2014	SUPPL-38	Labeling-Package Insert		Label is not available on this site.
12/18/2012	SUPPL-37	Labeling-Package Insert		Label is not available on this site.
03/23/2012	SUPPL-34	Labeling-Package Insert		Label is not available on this site.
11/22/2011	SUPPL-32	Labeling-Package Insert		Label is not available on this site.
07/26/2011	SUPPL-31	Labeling-Package Insert		Label is not available on this site.
02/16/2011	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
09/17/2010	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
05/17/2010	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
04/12/2010	SUPPL-21	Labeling		Label is not available on this site.
09/24/2009	SUPPL-17	Labeling		Label is not available on this site.
08/18/2009	SUPPL-14	Labeling		Label is not available on this site.
04/25/2008	SUPPL-11	Labeling		Label is not available on this site.
12/20/2006	SUPPL-5	Labeling		Label is not available on this site.
12/20/2006	SUPPL-4	Manufacturing (CMC)-New Strength		Label is not available on this site.