Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090383
Company: MICRO LABS

Products on ANDA 090383

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 090383

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/16/2011	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
10/26/2023	SUPPL-16	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
05/23/2023	SUPPL-15	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
05/23/2023	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
05/23/2023	SUPPL-13	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
05/23/2023	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
06/15/2020	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
08/22/2019	SUPPL-10	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
11/14/2016	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
11/14/2016	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
11/04/2014	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
11/04/2014	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
12/29/2012	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.