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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202968
Company: WATSON LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;10MG TABLET;ORAL Prescription AB No No
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;20MG TABLET;ORAL Prescription AB No No
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;40MG TABLET;ORAL Prescription AB No No
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;80MG TABLET;ORAL Prescription AB 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

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/01/2021 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.

EZETIMIBE AND SIMVASTATIN

TABLET;ORAL; 10MG;10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;10MG TABLET;ORAL Prescription No AB 209222 ALKEM LABS LTD
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;10MG TABLET;ORAL Prescription No AB 208831 AMNEAL PHARMS CO
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;10MG TABLET;ORAL Prescription No AB 200909 DR REDDYS LABS SA
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;10MG TABLET;ORAL Prescription No AB 208699 GLENMARK PHARMS LTD
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;10MG TABLET;ORAL Prescription No AB 202968 WATSON LABS INC
VYTORIN EZETIMIBE; SIMVASTATIN 10MG;10MG TABLET;ORAL Prescription Yes AB 021687 ORGANON

TABLET;ORAL; 10MG;20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;20MG TABLET;ORAL Prescription No AB 209222 ALKEM LABS LTD
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;20MG TABLET;ORAL Prescription No AB 208831 AMNEAL PHARMS CO
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;20MG TABLET;ORAL Prescription No AB 200909 DR REDDYS LABS SA
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;20MG TABLET;ORAL Prescription No AB 208699 GLENMARK PHARMS LTD
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;20MG TABLET;ORAL Prescription No AB 202968 WATSON LABS INC
VYTORIN EZETIMIBE; SIMVASTATIN 10MG;20MG TABLET;ORAL Prescription Yes AB 021687 ORGANON

TABLET;ORAL; 10MG;40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;40MG TABLET;ORAL Prescription No AB 209222 ALKEM LABS LTD
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;40MG TABLET;ORAL Prescription No AB 208831 AMNEAL PHARMS CO
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;40MG TABLET;ORAL Prescription No AB 200909 DR REDDYS LABS SA
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;40MG TABLET;ORAL Prescription No AB 208699 GLENMARK PHARMS LTD
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;40MG TABLET;ORAL Prescription No AB 202968 WATSON LABS INC
VYTORIN EZETIMIBE; SIMVASTATIN 10MG;40MG TABLET;ORAL Prescription Yes AB 021687 ORGANON

TABLET;ORAL; 10MG;80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;80MG TABLET;ORAL Prescription No AB 209222 ALKEM LABS LTD
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;80MG TABLET;ORAL Prescription No AB 208831 AMNEAL PHARMS CO
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;80MG TABLET;ORAL Prescription No AB 200909 DR REDDYS LABS SA
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;80MG TABLET;ORAL Prescription No AB 208699 GLENMARK PHARMS LTD
EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;80MG TABLET;ORAL Prescription No AB 202968 WATSON LABS INC
VYTORIN EZETIMIBE; SIMVASTATIN 10MG;80MG TABLET;ORAL Prescription Yes AB 021687 ORGANON
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