Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 007883
Company: TEVA WOMENS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANTABUSE DISULFIRAM 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
ANTABUSE DISULFIRAM 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
08/28/1951 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/29/2000 SUPPL-30 Labeling

Label is not available on this site.

02/21/1995 SUPPL-29 Labeling

Label is not available on this site.

03/27/1989 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

08/14/1987 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/28/1986 SUPPL-24 Labeling

Label is not available on this site.

05/20/1985 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

10/15/1984 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

04/01/1985 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1982 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

02/11/1982 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/20/1982 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/20/1980 SUPPL-14 Labeling

Label is not available on this site.

03/20/1980 SUPPL-13 Labeling

Label is not available on this site.

05/25/1979 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

09/26/1978 SUPPL-11 Labeling

Label is not available on this site.

02/21/1980 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

12/22/1978 SUPPL-9 Labeling

Label is not available on this site.

01/05/1977 SUPPL-8 Labeling

Label is not available on this site.

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