Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072051
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULINDAC SULINDAC 200MG 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
04/17/1991 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
05/09/2016 SUPPL-40 Labeling-Package Insert

Label is not available on this site.

04/15/2015 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

07/30/2010 SUPPL-36 Labeling-Package Insert

Label is not available on this site.

06/08/2009 SUPPL-35 Labeling

Label is not available on this site.

12/20/2007 SUPPL-32 Labeling

Label is not available on this site.

04/03/2006 SUPPL-27 Labeling

Label is not available on this site.

09/20/2002 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

10/22/2002 SUPPL-15 Labeling

Label is not available on this site.

06/13/2002 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

05/01/2002 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/2002 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/2001 SUPPL-11 Labeling

Label is not available on this site.

08/28/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

10/02/2000 SUPPL-9 Labeling

Label is not available on this site.

10/02/2000 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/16/2000 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

05/16/2000 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

03/07/2000 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/05/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/24/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/22/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/12/1994 SUPPL-1 Manufacturing (CMC)

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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