Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088483
Company: ODYSSEY PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANTABUSE DISULFIRAM 500MG TABLET;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/08/1983 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/88483ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/13/2014 SUPPL-27 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

11/18/2003 SUPPL-14 Labeling

Label is not available on this site.

06/14/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/2000 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

04/07/1997 SUPPL-10 Labeling

Label is not available on this site.

12/20/1994 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/11/1994 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/22/1993 SUPPL-7 Labeling

Label is not available on this site.

07/14/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/08/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

ANTABUSE

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 203916 MYLAN PHARMS INC
DISULFIRAM DISULFIRAM 500MG TABLET;ORAL Prescription No AB 091619 SIGMAPHARM LABS LLC
DISULFIRAM DISULFIRAM 500MG TABLET;ORAL Prescription No AB 202652 WEST-WARD PHARMS INT

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