Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080142
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULFISOXAZOLE SULFISOXAZOLE 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
03/06/1974 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
07/29/2002 SUPPL-72 Manufacturing (CMC)-Facility

Label is not available on this site.

03/12/2002 SUPPL-71 Manufacturing (CMC)-Facility

Label is not available on this site.

01/28/2000 SUPPL-69 Manufacturing (CMC)-Facility

Label is not available on this site.

11/23/1999 SUPPL-68 Manufacturing (CMC)-Facility

Label is not available on this site.

11/05/1999 SUPPL-67 Manufacturing (CMC)-Facility

Label is not available on this site.

11/05/1999 SUPPL-66 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

11/05/1999 SUPPL-65 Manufacturing (CMC)-Control

Label is not available on this site.

11/05/1999 SUPPL-64 Manufacturing (CMC)-Facility

Label is not available on this site.

08/20/1999 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

04/17/1996 SUPPL-60 Labeling

Label is not available on this site.

01/05/1993 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

08/14/1992 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

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