Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070719
Company: HERITAGE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;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
02/12/1986 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-28 Labeling-Package Insert

Label is not available on this site.

01/28/2008 SUPPL-25 Labeling

Label is not available on this site.

11/16/2006 SUPPL-20 Labeling

Label is not available on this site.

07/29/2002 SUPPL-15 Manufacturing (CMC)-Facility

Label is not available on this site.

09/12/2001 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

04/28/2000 SUPPL-13 Labeling

Label is not available on this site.

04/28/2000 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/28/2000 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

11/05/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/01/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/01/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/01/1994 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/29/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/29/1993 SUPPL-4 Labeling

Label is not available on this site.

12/18/1991 SUPPL-3 Labeling

Label is not available on this site.

08/30/1989 SUPPL-2 Labeling

Label is not available on this site.

05/13/1987 SUPPL-1 Labeling

Label is not available on this site.

INDOMETHACIN

CAPSULE;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Prescription No AB 090403 CADILA
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Prescription No AB 091276 GLENMARK GENERICS
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Prescription No AB 070719 HERITAGE PHARMA
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Prescription No AB 018851 HERITAGE PHARMS INC
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Prescription No AB 091240 HETERO LABS LTD III
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Prescription No AB 205215 JUBILANT GENERICS
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Prescription No AB 018858 MYLAN
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Prescription No AB 070673 SANDOZ
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Prescription No AB 091401 SUN PHARM INDS INC

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