Drugs@FDA: FDA Approved Drug Products

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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
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 073039 MYLAN
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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