Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202968
Company: WATSON LABS INC

Products on ANDA 202968

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 202968

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/26/2017	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
01/29/2025	SUPPL-10	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
10/01/2021	SUPPL-5	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
01/24/2020	SUPPL-4	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/16/2019	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/16/2019	SUPPL-2	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.