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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071795
Company: WATSON LABS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULINDAC SULINDAC 200MG TABLET;ORAL Prescription AB No Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/03/1988 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
11/21/2024 SUPPL-47 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
11/04/2024 SUPPL-45 Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
04/28/2021 SUPPL-44 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
12/17/2015 SUPPL-41 Labeling-Package Insert

Label is not available on this site.
05/09/2016 SUPPL-40 Labeling-Package Insert

Label is not available on this site.
10/08/2008 SUPPL-28 Labeling

Label is not available on this site.
02/05/2008 SUPPL-26 Labeling

Label is not available on this site.
06/05/2007 SUPPL-20 Labeling

Label is not available on this site.
02/17/2006 SUPPL-19 Labeling

Label is not available on this site.
04/25/2001 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.
10/25/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.
05/15/2002 SUPPL-14 Labeling

Label is not available on this site.
01/28/2000 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
04/15/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
04/15/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
03/22/1990 SUPPL-7 Labeling

Label is not available on this site.
10/15/1990 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
10/15/1990 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
06/29/1990 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
03/07/1989 SUPPL-1 Labeling

Label is not available on this site.

SULINDAC

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SULINDAC SULINDAC 200MG TABLET;ORAL Prescription No AB 072711 EPIC PHARMA
SULINDAC SULINDAC 200MG TABLET;ORAL Prescription No AB 072051 SUN PHARM INDUSTRIES
SULINDAC SULINDAC 200MG TABLET;ORAL Prescription No AB 071795 WATSON LABS
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