Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 208831
Company: AMNEAL PHARMS CO

Products on ANDA 208831

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208831

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/21/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/19/2024	SUPPL-14	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
12/19/2024	SUPPL-13	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/15/2021	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
01/29/2020	SUPPL-4	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
09/26/2019	SUPPL-2	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
03/22/2019	SUPPL-1	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.