Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 210095
Company: MAYNE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOLCAPONE TOLCAPONE 100MG 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
08/01/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

TOLCAPONE

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TASMAR TOLCAPONE 100MG TABLET;ORAL Prescription Yes AB 020697 BAUSCH
TOLCAPONE TOLCAPONE 100MG TABLET;ORAL Prescription No AB 210095 MAYNE PHARMA
TOLCAPONE TOLCAPONE 100MG TABLET;ORAL Prescription No AB 208937 NOVAST LABS
TOLCAPONE TOLCAPONE 100MG TABLET;ORAL Prescription No AB 204584 PAR PHARM INC

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