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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201890
Company: ANI PHARMS
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
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 Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/30/2024 SUPPL-12 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

05/30/2024 SUPPL-11 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

02/23/2021 SUPPL-10 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

01/29/2020 SUPPL-9 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

01/29/2020 SUPPL-8 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

04/02/2019 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

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