Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088482
Company: ODYSSEY PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANTABUSE DISULFIRAM 250MG 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
12/08/1983 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/88482ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/13/2014 SUPPL-37 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

11/15/2002 SUPPL-21 Labeling

Label is not available on this site.

11/15/2002 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

11/15/2002 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/09/2002 SUPPL-18 Labeling

Label is not available on this site.

04/09/2002 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/18/2001 SUPPL-16 Labeling

Label is not available on this site.

03/26/2001 SUPPL-15 Labeling

Label is not available on this site.

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

Label is not available on this site.

05/02/2001 SUPPL-13 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/07/2000 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

04/07/1997 SUPPL-11 Labeling

Label is not available on this site.

12/20/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/11/1994 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/22/1993 SUPPL-8 Labeling

Label is not available on this site.

04/04/1990 SUPPL-7 Manufacturing (CMC)

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; 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 MALTA
DISULFIRAM DISULFIRAM 250MG TABLET;ORAL Prescription No AB 091563 CHARTWELL MOLECULES
DISULFIRAM DISULFIRAM 250MG TABLET;ORAL Prescription No AB 203916 MYLAN PHARMS INC
DISULFIRAM DISULFIRAM 250MG TABLET;ORAL Prescription No AB 091619 SIGMAPHARM LABS LLC
DISULFIRAM DISULFIRAM 250MG TABLET;ORAL Prescription No AB 202652 WEST-WARD PHARMS INT

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