Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200831
Company: WATSON LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EZETIMIBE EZETIMIBE 10MG 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
06/12/2017 ORIG-1 Approval Not Applicable

Label is not available on this site.

EZETIMIBE

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EZETIMIBE EZETIMIBE 10MG TABLET;ORAL Prescription No AB 209234 ALKEM LABS LTD
EZETIMIBE EZETIMIBE 10MG TABLET;ORAL Prescription No AB 208803 AMNEAL PHARMS CO
EZETIMIBE EZETIMIBE 10MG TABLET;ORAL Prescription No AB 208332 APOTEX INC
EZETIMIBE EZETIMIBE 10MG TABLET;ORAL Prescription No AB 209838 AUROBINDO PHARMA LTD
EZETIMIBE EZETIMIBE 10MG TABLET;ORAL Prescription No AB 078560 GLENMARK PHARMS LTD
EZETIMIBE EZETIMIBE 10MG TABLET;ORAL Prescription No AB 201790 MYLAN
EZETIMIBE EZETIMIBE 10MG TABLET;ORAL Prescription No AB 207311 OHM LABS INC
EZETIMIBE EZETIMIBE 10MG TABLET;ORAL Prescription No AB 203931 SANDOZ INC
EZETIMIBE EZETIMIBE 10MG TABLET;ORAL Prescription No AB 078724 TEVA PHARMS USA
EZETIMIBE EZETIMIBE 10MG TABLET;ORAL Prescription No AB 200831 WATSON LABS INC
EZETIMIBE EZETIMIBE 10MG TABLET;ORAL Prescription No AB 204331 ZYDUS PHARMS
ZETIA EZETIMIBE 10MG TABLET;ORAL Prescription Yes AB 021445 MSD INTL GMBH

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