Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090690
Company: SUN PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ENTACAPONE ENTACAPONE 200MG 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
07/16/2012 ORIG-1 Approval

Label is not available on this site.

ENTACAPONE

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
COMTAN ENTACAPONE 200MG TABLET;ORAL Prescription Yes AB 020796 ORION PHARMA
ENTACAPONE ENTACAPONE 200MG TABLET;ORAL Prescription No AB 205792 AJANTA PHARMA LTD
ENTACAPONE ENTACAPONE 200MG TABLET;ORAL Prescription No AB 078941 ATLANTIDE
ENTACAPONE ENTACAPONE 200MG TABLET;ORAL Prescription No AB 203437 AUROBINDO PHARMA LTD
ENTACAPONE ENTACAPONE 200MG TABLET;ORAL Prescription No AB 207210 MACLEODS PHARMS LTD
ENTACAPONE ENTACAPONE 200MG TABLET;ORAL Prescription No AB 090690 SUN PHARM
ENTACAPONE ENTACAPONE 200MG TABLET;ORAL Prescription No AB 206669 SUNSHINE

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