Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 072710
Company: EPIC PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
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
04/28/2021 SUPPL-15 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

05/09/2016 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

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

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.

03/17/1992 SUPPL-2 Labeling

Label is not available on this site.

05/31/1991 SUPPL-1 Labeling

Label is not available on this site.

SULINDAC

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English