Drugs@FDA: FDA Approved Drug Products

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

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 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 201890 IMPAX LABS INC
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 MSD INTL

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 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 201890 IMPAX LABS INC
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 MSD INTL

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 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 201890 IMPAX LABS INC
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 MSD INTL

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 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 201890 IMPAX LABS INC
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 MSD INTL

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