Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086890
Company: WATSON LABS TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DISULFIRAM DISULFIRAM 500MG TABLET;ORAL Discontinued None 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
03/31/1981 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/14/1998 SUPPL-22 Labeling

Label is not available on this site.

05/13/1992 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

01/28/1991 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/31/1991 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/14/1988 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/14/1988 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/29/1985 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/29/1985 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/29/1985 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/26/1982 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

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