Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089590
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULFASALAZINE SULFASALAZINE 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
10/19/1987 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
05/15/2002 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

11/21/2001 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/2001 SUPPL-25 Labeling

Label is not available on this site.

08/21/2001 SUPPL-24 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/21/2001 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/18/2001 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

02/05/2001 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

03/24/2000 SUPPL-20 Labeling

Label is not available on this site.

05/16/2000 SUPPL-19 Manufacturing (CMC)-Facility

Label is not available on this site.

05/16/2000 SUPPL-18 Manufacturing (CMC)-Facility

Label is not available on this site.

11/23/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/23/1998 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

12/23/1998 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/25/1998 SUPPL-13 Labeling

Label is not available on this site.

12/05/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/24/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/06/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/22/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/12/1994 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/21/1991 SUPPL-6 Labeling

Label is not available on this site.

04/03/1991 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/11/1991 SUPPL-3 Labeling

Label is not available on this site.

09/26/1990 SUPPL-2 Labeling

Label is not available on this site.

12/11/1991 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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