Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 073262
Company: EPIC PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULINDAC SULINDAC 200MG TABLET;ORAL Discontinued None No No
SULINDAC SULINDAC 150MG TABLET;ORAL Discontinued None 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
09/06/1991 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-21 Labeling-Package Insert

Label is not available on this site.

06/24/2009 SUPPL-20 Labeling

Label is not available on this site.

12/20/2007 SUPPL-18 Labeling

Label is not available on this site.

06/23/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/13/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/05/1994 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/05/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/17/1993 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

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