Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072713
Company: FOSUN PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULINDAC SULINDAC 200MG 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
08/30/1991 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
04/28/2021 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

04/19/2021 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/09/2016 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

12/16/2002 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

04/19/2002 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

08/31/2001 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/05/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/03/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/26/1996 SUPPL-3 Labeling

Label is not available on this site.

01/24/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/07/1992 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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