Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070624
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/04/1985 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-33 Labeling-Patient Package Insert, Labeling-Medication Guide

Label is not available on this site.

04/28/2008 SUPPL-29 Labeling

Label is not available on this site.

06/27/2006 SUPPL-24 Labeling

Label is not available on this site.

09/26/2002 SUPPL-20 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/22/2002 SUPPL-19 Labeling

Label is not available on this site.

02/25/1998 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/16/1996 SUPPL-16 Labeling

Label is not available on this site.

10/05/1993 SUPPL-15 Labeling

Label is not available on this site.

05/02/1994 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/20/1993 SUPPL-12 Labeling

Label is not available on this site.

12/10/1992 SUPPL-11 Labeling

Label is not available on this site.

01/31/1990 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/20/1989 SUPPL-9 Labeling

Label is not available on this site.

06/30/1989 SUPPL-8 Labeling

Label is not available on this site.

02/16/1989 SUPPL-7 Labeling

Label is not available on this site.

04/14/1988 SUPPL-6 Labeling

Label is not available on this site.

09/24/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/20/1986 SUPPL-4 Labeling

Label is not available on this site.

08/14/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/08/1986 SUPPL-2 Labeling

Label is not available on this site.

INDOMETHACIN

CAPSULE;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Prescription No AB 090403 CADILA
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Prescription No AB 091276 GLENMARK GENERICS
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Prescription No AB 070756 HERITAGE PHARMA
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Prescription No AB 018851 HERITAGE PHARMS INC
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Prescription No AB 091240 HETERO LABS LTD III
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Prescription No AB 205215 JUBILANT GENERICS
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Prescription No AB 070624 MYLAN
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Prescription No AB 070674 SANDOZ
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Prescription No AB 091401 SUN PHARM INDS INC

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