Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073039
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULINDAC SULINDAC 200MG TABLET;ORAL Prescription AB No No
SULINDAC SULINDAC 150MG 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
06/22/1993 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-18 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/22/2015 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

08/13/2010 SUPPL-16 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

05/08/2008 SUPPL-10 Labeling

Label is not available on this site.

05/16/2006 SUPPL-8 Labeling

Label is not available on this site.

09/18/2002 SUPPL-3 Labeling

Label is not available on this site.

02/05/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/18/1996 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

TABLET;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SULINDAC SULINDAC 150MG TABLET;ORAL Prescription No AB 072710 EPIC PHARMA
SULINDAC SULINDAC 150MG TABLET;ORAL Prescription No AB 073039 MYLAN
SULINDAC SULINDAC 150MG TABLET;ORAL Prescription No AB 072050 SUN PHARM INDUSTRIES
SULINDAC SULINDAC 150MG TABLET;ORAL Prescription No AB 071891 WATSON LABS

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