Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071149
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INDOMETHACIN INDOMETHACIN 50MG 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
03/18/1987 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-18 Labeling-Package Insert

Label is not available on this site.

08/13/2002 SUPPL-15 Labeling

Label is not available on this site.

05/29/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/2000 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

07/02/1996 SUPPL-12 Labeling

Label is not available on this site.

04/29/1996 SUPPL-11 Labeling

Label is not available on this site.

07/15/1994 SUPPL-10 Labeling

Label is not available on this site.

05/11/1994 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/08/1991 SUPPL-7 Labeling

Label is not available on this site.

04/01/1991 SUPPL-6 Labeling

Label is not available on this site.

02/24/1989 SUPPL-5 Labeling

Label is not available on this site.

02/08/1989 SUPPL-4 Labeling

Label is not available on this site.

11/23/1992 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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