Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206672
Company: CASI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ENTECAVIR ENTECAVIR 0.5MG TABLET;ORAL Prescription AB No No
ENTECAVIR ENTECAVIR 1MG 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
05/11/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

ENTECAVIR

TABLET;ORAL; 0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BARACLUDE ENTECAVIR 0.5MG TABLET;ORAL Prescription Yes AB 021797 BRISTOL MYERS SQUIBB
ENTECAVIR ENTECAVIR 0.5MG TABLET;ORAL Prescription No AB 205824 ACCORD HLTHCARE
ENTECAVIR ENTECAVIR 0.5MG TABLET;ORAL Prescription No AB 206652 AMNEAL PHARMS
ENTECAVIR ENTECAVIR 0.5MG TABLET;ORAL Prescription No AB 206217 AUROBINDO PHARMA LTD
ENTECAVIR ENTECAVIR 0.5MG TABLET;ORAL Prescription No AB 208721 BRECKENRIDGE
ENTECAVIR ENTECAVIR 0.5MG TABLET;ORAL Prescription No AB 212126 BRIGHTGENE
ENTECAVIR ENTECAVIR 0.5MG TABLET;ORAL Prescription No AB 206672 CASI PHARMS INC
ENTECAVIR ENTECAVIR 0.5MG TABLET;ORAL Prescription No AB 206872 CIPLA
ENTECAVIR ENTECAVIR 0.5MG TABLET;ORAL Prescription No AB 205740 HETERO LABS LTD V
ENTECAVIR ENTECAVIR 0.5MG TABLET;ORAL Prescription No AB 206226 MYLAN
ENTECAVIR ENTECAVIR 0.5MG TABLET;ORAL Prescription No AB 206294 PAR PHARM INC
ENTECAVIR ENTECAVIR 0.5MG TABLET;ORAL Prescription No AB 208782 PRINSTON INC
ENTECAVIR ENTECAVIR 0.5MG TABLET;ORAL Prescription No AB 202122 TEVA PHARMS USA
ENTECAVIR ENTECAVIR 0.5MG TABLET;ORAL Prescription No AB 212201 YAOPHARMA CO LTD
ENTECAVIR ENTECAVIR 0.5MG TABLET;ORAL Prescription No AB 206745 ZYDUS PHARMS

TABLET;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BARACLUDE ENTECAVIR 1MG TABLET;ORAL Prescription Yes AB 021797 BRISTOL MYERS SQUIBB
ENTECAVIR ENTECAVIR 1MG TABLET;ORAL Prescription No AB 205824 ACCORD HLTHCARE
ENTECAVIR ENTECAVIR 1MG TABLET;ORAL Prescription No AB 206652 AMNEAL PHARMS
ENTECAVIR ENTECAVIR 1MG TABLET;ORAL Prescription No AB 206217 AUROBINDO PHARMA LTD
ENTECAVIR ENTECAVIR 1MG TABLET;ORAL Prescription No AB 208721 BRECKENRIDGE
ENTECAVIR ENTECAVIR 1MG TABLET;ORAL Prescription No AB 212126 BRIGHTGENE
ENTECAVIR ENTECAVIR 1MG TABLET;ORAL Prescription No AB 206672 CASI PHARMS INC
ENTECAVIR ENTECAVIR 1MG TABLET;ORAL Prescription No AB 206872 CIPLA
ENTECAVIR ENTECAVIR 1MG TABLET;ORAL Prescription No AB 205740 HETERO LABS LTD V
ENTECAVIR ENTECAVIR 1MG TABLET;ORAL Prescription No AB 206226 MYLAN
ENTECAVIR ENTECAVIR 1MG TABLET;ORAL Prescription No AB 206294 PAR PHARM INC
ENTECAVIR ENTECAVIR 1MG TABLET;ORAL Prescription No AB 208782 PRINSTON INC
ENTECAVIR ENTECAVIR 1MG TABLET;ORAL Prescription No AB 202122 TEVA PHARMS USA
ENTECAVIR ENTECAVIR 1MG TABLET;ORAL Prescription No AB 212201 YAOPHARMA CO LTD
ENTECAVIR ENTECAVIR 1MG TABLET;ORAL Prescription No AB 206745 ZYDUS PHARMS

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