Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070900
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Discontinued None No No
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;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
02/09/1987 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-22 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/27/2006 SUPPL-21 Labeling

Label is not available on this site.

09/10/2002 SUPPL-12 Labeling

Label is not available on this site.

05/16/2000 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

05/16/2000 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

12/05/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/24/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/17/1996 SUPPL-7 Labeling

Label is not available on this site.

08/13/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/29/1996 SUPPL-5 Labeling

Label is not available on this site.

01/12/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/02/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/12/1989 SUPPL-2 Labeling

Label is not available on this site.

02/24/1988 SUPPL-1 Labeling

Label is not available on this site.

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