Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087665
Company: BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULFINPYRAZONE SULFINPYRAZONE 100MG 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
09/17/1982 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
01/02/2003 SUPPL-22 Labeling

Label is not available on this site.

12/21/1999 SUPPL-21 Manufacturing (CMC)-Facility

Label is not available on this site.

08/27/1999 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/20/1999 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/12/1991 SUPPL-12 Labeling

Label is not available on this site.

03/08/1991 SUPPL-11 Labeling

Label is not available on this site.

07/14/1989 SUPPL-10 Labeling

Label is not available on this site.

03/20/1987 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/22/1985 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/22/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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