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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080197
Company: CHARTWELL
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
11/12/1973 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
11/21/1997 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

06/10/1994 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

04/12/1994 SUPPL-24 Labeling

Label is not available on this site.

05/28/1993 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

05/28/1993 SUPPL-22 Labeling

Label is not available on this site.

04/26/1991 SUPPL-21 Labeling

Label is not available on this site.

02/08/1991 SUPPL-20 Labeling

Label is not available on this site.

08/01/1989 SUPPL-19 Labeling

Label is not available on this site.

06/29/1988 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/29/1988 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/13/1983 SUPPL-11 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 PFIZER
SULFASALAZINE SULFASALAZINE 500MG TABLET;ORAL Prescription No AB 080197 CHARTWELL
SULFASALAZINE SULFASALAZINE 500MG TABLET;ORAL Prescription No AB 040349 NUVO PHARMS INC
SULFASALAZINE SULFASALAZINE 500MG TABLET;ORAL Prescription No AB 085828 WATSON LABS
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