Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085828
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULFASALAZINE SULFASALAZINE 500MG 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
10/21/1977 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
02/25/2015 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

02/25/2015 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

08/21/2013 SUPPL-36 Labeling-Package Insert

Label is not available on this site.

12/31/2010 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

05/05/2003 SUPPL-34 Labeling

Label is not available on this site.

10/27/1998 SUPPL-33 Labeling

Label is not available on this site.

04/23/1998 SUPPL-32 Labeling

Label is not available on this site.

10/08/1997 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

10/08/1997 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

05/27/1997 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

03/31/1993 SUPPL-28 Labeling

Label is not available on this site.

07/22/1991 SUPPL-27 Labeling

Label is not available on this site.

05/21/1991 SUPPL-26 Labeling

Label is not available on this site.

08/15/1988 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/15/1988 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

08/15/1988 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

08/15/1988 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/04/1988 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/20/1987 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/20/1987 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/20/1987 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/15/1986 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/22/1983 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/13/1983 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/13/1983 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

SULFASALAZINE

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZULFIDINE SULFASALAZINE 500MG TABLET;ORAL Prescription Yes AB 007073 PHARMACIA AND UPJOHN
SULFASALAZINE SULFASALAZINE 500MG TABLET;ORAL Prescription No AB 040349 VINTAGE PHARMS
SULFASALAZINE SULFASALAZINE 500MG TABLET;ORAL Prescription No AB 085828 WATSON LABS

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