Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091563
Company: CHARTWELL MOLECULES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DISULFIRAM DISULFIRAM 250MG TABLET;ORAL Prescription AB No No
DISULFIRAM DISULFIRAM 500MG 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
12/31/2012 ORIG-1 Approval

Label is not available on this site.

DISULFIRAM

TABLET;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANTABUSE DISULFIRAM 250MG TABLET;ORAL Prescription No AB 088482 ODYSSEY PHARMS
DISULFIRAM DISULFIRAM 250MG TABLET;ORAL Prescription No AB 091681 ALVOGEN
DISULFIRAM DISULFIRAM 250MG TABLET;ORAL Prescription No AB 091563 CHARTWELL MOLECULES
DISULFIRAM DISULFIRAM 250MG TABLET;ORAL Prescription No AB 202652 HIKMA
DISULFIRAM DISULFIRAM 250MG TABLET;ORAL Prescription No AB 091619 SIGMAPHARM LABS LLC

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANTABUSE DISULFIRAM 500MG TABLET;ORAL Prescription No AB 088483 ODYSSEY PHARMS
DISULFIRAM DISULFIRAM 500MG TABLET;ORAL Prescription No AB 091563 CHARTWELL MOLECULES
DISULFIRAM DISULFIRAM 500MG TABLET;ORAL Prescription No AB 202652 HIKMA
DISULFIRAM DISULFIRAM 500MG TABLET;ORAL Prescription No AB 091619 SIGMAPHARM LABS LLC

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