Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072711
Company: EPIC PHARMA
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
03/25/1991 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-10 Labeling-Package Insert

Label is not available on this site.

05/28/2015 SUPPL-9 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/15/2010 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

10/01/2009 SUPPL-5 Labeling

Label is not available on this site.

05/13/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/12/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/27/1992 SUPPL-2 Labeling

Label is not available on this site.

05/06/1991 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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